Cosmetic Formulation Principles for Personal Care

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Rinse-Off Products

Rinse-off products differ from leave-on products because they are only on the body transiently and are then washed away.

  • Therefore, they are not generally used to deliver functional ingredients for absorption.

  • They must deliver their function(s) rapidly.

  • They might contain some minimal amount of ingredients designed to remain after rinsing.

  • They can better tolerate the presence of ingredients that might cause irritation or allergies than a leave-on product.

  • Mostly, rinse-off products for personal care are used as cleansers, so surfactants and solvents are key ingredients.


Cleaning – A Bit of History

  • Ancient civilizations employed various methods for cleaning skin and hair using natural substances.

  • Egyptian civilization: used soap-like materials made from animal fats, vegetable oils, and alkaline salts; oils and fragrances for hair.

  • Mesopotamian civilization: used water, clay, and plant-based substances; olive and castor oils were used.

  • Greek and Roman civilization: used water, oils, and other botanicals; olive oil scented with herbs or flowers; bathhouses were very popular.


Key Roles of Surfactants

  • Emulsifiers

  • Detergents

  • Wetting agents

  • Solubilizing agents

  • Dispersing agents

  • Suspending agents

  • Foaming and antifoaming agents


Detergency

  • If detergents clean mainly by reduction of surface tension, then why doesn't everyone just use SLES (sodium laureth sulphate)?

  • SLES produces low surface tension, is safe, and is cheap.

  • However, low surface tension alone is not sufficient for effective cleaning.


Surface Tension vs Interfacial Tension

  • For general dirt (soil), water needs to get in to reduce forces between molecules.

  • Surface tension matters for wetting the surface – low surface tension allows water to reach dirt.

  • Once water reaches dirt, removal depends on interfacial tension (dirt-water).

  • When optimized, low interfacial tension allows oil to detach from the surface and break into droplets.

  • A monolayer of water reduces van der Waals attraction by orders of magnitude (1/r⁶ dependency).

  • Low interfacial tension and curvature are needed more than just low surface tension.


Detergency Mechanisms

  • Solubilization (micellar): oil molecules partition into micelles; works very well for small amounts of oil; true for most hand washing.

  • But if you coat your hand in olive oil and wash with a foamed hand cleanser, it needs an awful lot of soap.

  • Emulsification: oil forms droplets, coated with surfactant, and stabilized against coalescence.

  • Shampoo and dishwashing are emulsification-dominated.


Achieving Good Detergency

  • You want to achieve low interfacial tension at the wash temperature.

  • HLD = 0 is good for solubilization but poor for emulsion stability.

  • Droplets removed from surfaces might easily contact and spread on another.

  • Therefore, an HLD slightly below zero is best.

  • Most commercial detergents contain polymeric surfactants – great solubilizers but too slow when used alone.

  • Use conventional small molecules to get oil off the surface, and polymeric surfactants to prevent re-deposition.

  • A system of around 5-15% anionics and 5-15% non-ionics tends to work well.

  • Polymers used for steric stabilization; anionic cellulosics stick to cellulose fibers and repel anionic dirt particles; PET-PEO di-block polymers stick to PET fibers; polyacrylics are the workhorse anionics for sequestration of Ca ions, charge stabilization, and avoidance of re-deposition.


Consumer Perspective and Technical Quality

Consumer perspective:

  • Neutral or pleasant odor and color.

  • Easy to rub on with appropriate foaming property.

  • Easy to spread.

  • Pleasant feeling during application.

  • Non-oily/non-greasy feeling.

  • Leaves no residue.

  • Moisturizes the skin while cleaning.

  • Non-comedogenic.

  • Well tolerated and non-allergenic.

  • Hand sanitizers: do not dry the skin, but kill bacteria and viruses.

Technical quality:

  • Long-term stability.

  • Smooth texture.

  • No microbiological contamination and growth.

  • Appropriate rheological properties.

  • Appropriate foaming activity.

  • Appropriate performance.

  • Appropriate pH.

  • Dermatological safety/reduced irritancy.


Choosing Detergents in Wash Products

  • (Title slide – limited content)


Additional Formulation Notes

  • Colorants may contribute to marketing appeal; both natural and synthetic colorants can be used; titanium dioxide or glycol stearate used as opacifiers.

  • Fragrances mask odor of raw ingredients but may be highly irritative, especially for sensitive skin.

  • Preservatives provide protection against microbiological contamination (parabens, phenoxyethanol, benzoates).

  • pH buffers may be used: alkaline solutions for saponification (potassium hydroxide, sodium hydroxide, ammonium hydroxide); citric acid and lactic acid shift pH to acidic range (closer to natural skin pH, less irritant); pH buffers like triethanolamine may be needed to thicken formulation via neutralizing thickeners.


Antibacterial Agents and Other Ingredients

  • Antibacterial agents are widely used; may be beneficial for acne, superficial skin infections (folliculitis), and infection control.

  • Most commonly used compound is triclosan (safety/efficacy currently being investigated by FDA).

  • Additional examples: benzoyl peroxide, lactic acid (soaps with higher lactic acid have acidic pH, thought to be antibacterial).

  • Absorbents mainly used in facial masks to absorb sebum (zinc oxide, titanium dioxide, kaolin, calamine, clay, natural mud).

  • Astringents are major ingredients in facial toners; tighten pores and refresh skin (alcohol, witch hazel).

  • Certain soaps contain vitamins and exotic natural ingredients (derived from fruits, other plants).


Solvent Cleaners

  • Solvents (EtOH, IPA, etc.) are great for industrial cleaning but perceived as "bad" by consumers.

  • Subject to ever-more-restrictive rules on volatile organic content (VOC).

  • Purely aqueous cleaning with modest surfactant can be fine for many soils but useless when soil requires solvency.

  • A compromise is to deliver solvent within an aqueous environment – perceived as user-friendly and environmentally benign.

  • If solvent is fully water-soluble, unlikely to be a good solvent for water-insoluble oil.

  • An effective solution for water-insoluble solvents is to deliver them as a microemulsion.


Why a Microemulsion?

  • If drops are relatively large, the amount of surfactant required to cover and stabilize the emulsion is modest (advantage).

  • However, such emulsions are generally not successful because the emulsion must be stable for practical use – the surfactant shell around the solvent drop provides a barrier to effective cleaning.

  • The more stable the emulsion (so it can be shipped and used conveniently), the less effective it is as a cleaner.

  • Therefore, a microemulsion with smaller droplet size can be more effective, although it takes higher amounts of surfactant.

  • Applications: industrial adhesive removal, degreasing and tar removal.


Foams

  • When a group of spherical bubbles meet so that most water has disappeared ("dry" foam), the most energy-efficient form of packing involves polyhedral faces.

  • Making foams is easy – keeping them needs a surfactant.

  • Key properties: elasticity, disjoining pressure, resistance to ripening, resistance to draining, resistance to defects.

  • Foam bubbles are made from film walls, linked by Plateau borders which meet at nodes.


Anti-Foams

  • Antifoams can be pure oils, pure hydrophobic particles, or blends.

  • The problem is to make them with small droplet size – using a surfactant.

  • Silicones tend to be most successful at 0.2% surfactant because they are harder to emulsify than oils.

  • Another class of antifoams destroy the surfactant itself rather than the foam.

  • Hard water when surfactants are fatty acid salts (e.g., sodium stearate) – calcium ions cause stearate to become insoluble and foam disappears.

  • A small amount of cationic surfactant can rapidly destroy an anionic surfactant foam.

  • Adding a lot of salt to a foam with large electrostatic disjoining pressure can reduce the disjoining pressure, thin the foam, and make it more susceptible to collapse.

  • Added to carpet extractors and scrubbers to protect vacuum motors from liquid intake.


Surfactant Types and Properties

Non-ionic:

  • Low stable foam, supports other surfactants, emulsifiers, solubilizers.

  • Examples: glycerol-based (emulsifiers), sorbitol-based (solubilizers), e.g., sorbitan isostearate, PEG-castor oil, Cocamide DEA, Lauramide MEA.

Anionic (negative charge):

  • Wetting agents, good detergency, cleaning, high coarse foam.

  • Examples: alkyl and alkyl ethoxy sulfates, alkyl aryl sulfonates, alpha olefin sulfonates, e.g., sodium lauryl ether sulfate, ammonium laureth sulfate, sodium lauryl sarcosinate.

Anionic soaps:

  • Hard soap = sodium salts of fatty acids (sodium cocoate, sodium palmate).

  • Soft soap = potassium salts of fatty acids (potassium laurate, potassium palmate).

Cationic (positive charge):

  • Conditioning agents, antistatic, very low foaming; cannot mix with anionics.

  • Examples: quaternary ammonium salts (Quaternium-80, Behentrimonium chloride, silicone quaternium).

Amphoteric or Zwitterionic (dual charge):

  • Mild-to-fine foaming, used in 2-in-1 shampoo.

  • Contain dual functional groups: anionic in alkali, nonionic at neutral pH, or cationic in acid.

  • Example: Cocoamido propyl betaine.


Surfactant Comparison Table

PropertyNonionicsAnionicsCationicsAmphoteric
Foamlow to mediummedium to highlowhigh
Wettinggoodgood to excellentpoor-
Emulsificationgood to excellentgoodpoor-
Detergencygood to excellentgood to excellentpoor-
Irritation (skin & eye)mild to severemild to severe-very mild
Compatibility with other surfactantscompatible with all typesincompatible with cationsincompatible with anions-

Good Cleansing Formulation Principles

  • Good cleansing – choosing the right surfactant or combination based on expectations.

  • Good viscosity – micellar arrangement/behavior, co-surfactants, thickeners, electrolytes, compatibility of ingredients and processes.

  • Foaming – based on selection of surfactants depending on the brief.

  • No precipitates/separation – all ingredients well solubilized, no chelation.

  • Reduced irritancy – reduced harshness, superfatting agents, pH is skin compatible.


Surfactant Irritancy Mechanisms and Reduction

Mechanisms of irritancy:

  1. Surfactants bind to skin proteins and denature them.

  2. Bind to lipid matrix, making skin permeable.

  3. Disrupt natural moisturizing factor (NMF).

  4. Stimulate anti-inflammatory response by interacting with epidermal cells.

  5. Stimulate oxidative response.

Methods to reduce irritancy:

  1. Use only mild surfactants (non-ionics/ethoxylated anionics).

  2. Blend with amphoterics (betaines).

  3. Polymer/hydrolyzed protein additives.

  4. Refatting agents/refatteners (fatty acid esters, fatty alcohols, various oils).

  5. Antioxidants.


Fragrance Use in Rinse-Off Products (EU Regulations)

  • All ingredients added as fragrances must comply with IFRA's code of conduct.

  • Fragrances may be classified as H412 or H413.

  • Products recommended/advertised for babies may not contain fragrances.

  • Nitro musk and polycyclic musk compounds are prohibited.

  • The following fragrances are permitted only up to 0.01%:

    • Benzyl alcohol, Amyl cinnamal, Cinnamyl alcohol, Citral, Eugenol, Hydroxycitronellal, Isoeugenol, Amylcinnamyl alcohol, Benzyl salicylate, Cinnamal, Coumarin, Geraniol, Hydroxyisohexyl 3-cyclohexene carboxaldehyde, Anise alcohol, Benzyl cinnamate, Farnesol, Butylphenyl methylpropional, Linalool, Benzyl benzoate, Citronellol, Hexyl cinnamal, Limonene, Methyl-2-octynoate, Alpha-isomethyl ionone, Evernia prunastri extract, Evernia furfuracea extract.


Resources and Further Reading

  • Baki, G., & Alexander, K. S. (2015). Introduction to cosmetic formulation and technology.

  • Carli, B. (2016). Cosmetic Formulations: An Advanced Guide.

  • Barel, A. O., Paye, M., & Maibach, H. I. (2014). Handbook of cosmetic science and technology (4th ed.).

  • Darvin, M., & Lademann, J. (2007). Dermatologic, Cosmeceutic, and Cosmetic Development.

  • Tadros, T. F. (2016 & 2018). Formulation Science and Technology & Formulations: In Cosmetic and Personal Care.

  • Barton, S. et al. (Eds.). (2020). Discovering Cosmetic Science. Royal Society of Chemistry.


Anionic Surfactant – Sodium Laureth Sulfate (SLES)

  • INCI: Sodium Laureth Sulfate (Sodium Lauryl Ether Sulfate) – NOT SLS.

  • Very effective surfactant and foaming agent, derived from palm oil or coconut oil.

  • Low cost.

  • Has mild irritancy to the skin (whereas SLS is a known irritant).

  • Typically has pH of around 7–9 at 2% in water.


Anionic Surfactant – Sodium Coco Sulfate

  • INCI: Sodium Coco Sulfate; minimum 90% active content.

  • Natural, high foaming, anionic surfactant suitable for Ecocert formulas where thickness is required.

  • Can be irritating to the skin – addition of mildness-improving ingredients recommended.

  • Works best in pH range between 6 and 12; may require a chelating agent.


Anionic Surfactant – Sodium Cocoyl Isethionate (SCI)

  • INCI: Sodium Cocoyl Isethionate (powder or granules).

  • Very mild surfactant designed to work effectively in hard water.

  • Derived from coconut fatty acids; fully biodegradable.

  • Gentle enough for baby products and personal cleansers for sensitive areas (e.g., eye-makeup removers).

  • Leaves a silky skin feel whilst exhibiting excellent lathering properties.

  • Usage: 3–40% in heated phase of surfactant formulations.

  • Solubility: soluble in water.

  • pH (1% in water): 4.5–7.5.


Anionic Surfactant – Sodium Lauryl Sulfoacetate (SLSA)

  • INCI: Sodium Lauryl Sulfoacetate; minimum 65% active content.

  • Mild surfactant perfect for powdered bubble baths, shampoos, cleansing creams, and bath bombs.

  • Naturally derived from palm and coconut oils.

  • Offers rich lather without irritation potential of some other foam-building surfactants.

  • Due to large molecular size, will not penetrate skin or mucous membranes.

  • Non-irritating to skin up to 70%; non-irritating to eyes up to 3%.

  • Usage: 0.5–3% in skin care applications, baby products, pet products; 2.0–10% in body washes, soaks, shampoos.


Amphoteric Surfactant – Cocamidopropyl Betaine

  • 29–31% active content.

  • Mild co-surfactant compatible with anionic, non-ionic, and cationic surfactants; also useful as primary surfactant.

  • Effective cleanser, foam booster, and increases viscosity of finished product.

  • Excellent conditioning and antistatic agent.

  • Common in shampoos, conditioners, bubble baths, cleansing lotions, hand soaps.

  • Palm-free, derived from coconut oil.

  • Solubility: water soluble.

  • Usage: 4–10%.

  • pH: 4–12.


Non-Ionic Surfactants – Coco and Decyl Glucoside

Coco Glucoside:

  • 51–53% active content.

  • Non-ionic surfactant used as foaming, cleansing, conditioning, and thickening agent.

  • Derived from coconut and/or palm oil and corn sugars; completely biodegradable; gentle on all skin and hair types.

  • Works best in pH between 4 and 12.

Decyl Glucoside:

  • 51–55% active content.

  • Extremely mild and gentle non-ionic surfactant naturally derived from sugar.

  • Recommended for sensitive skin, facial wash products, shampoo, and body wash.

  • Generates exceptional fine and stable foam.

  • Readily biodegradable, low toxicity, extremely mild, performs well in hard water.

  • Non-irritating even at high concentrations with extended contact (24 hours).

  • Works best in pH between 4 and 12.


Non-Ionic Surfactant – Lauryl Glucoside

  • 50–53% active content.

  • Natural surfactant made from coconut oil and/or palm oil and sugar.

  • Very gentle – popular in products for sensitive skin and baby products.

  • Part of the alkyl glycoside family (APGs).

  • Made from renewable, sustainable raw materials; readily biodegradable.

  • Works best in pH between 4 and 12.


Superfatting Additive – Lamesoft PO 65

  • INCI: Coco Glucoside and Glyceryl Oleate (superfatting).

  • Naturally derived from coconut and sunflower oil.

  • High-performance additive that supports moisturization claims in surfactant systems.

  • Softens and conditions skin by depositing glyceryl oleate on its surface.

  • Lipid layer enhancer for surfactant-based cleansers.

  • Improves mildness of formulation; enhances viscosity in sulfate-free systems.

  • Cold processable – saves time and energy.

  • Can be used in clear, opacified, and pearlized formulations.

  • 100% naturally derived.

  • Usage: between 1–5%:

    • 1%: proven lipid layer enhancement in 'light' formulas.

    • 3%: perceivable skin softness and smoothness.

    • 5%: 24-hour moisturization.


Cationic Surfactant – BTMS-50

  • INCI: Behentrimonium Methosulfate (&) Cetyl Alcohol (&) Butylene Glycol.

  • Natural emulsifying wax; can emulsify creams, lotions, and scrubs leaving soft silky feeling.

  • Most used to make hair conditioners.

  • Cationic (positively charged) – conditioning agent giving excellent detangling, antistatic, and softening properties in leave-on and rinse-off hair care.

  • Extremely popular in solid bar recipes.

  • Contains 50% active content (BTMS-25 has 25%, BTMS-80 has 80%, palm-free).

  • Comes as easy-to-use flakes.

  • Potential applications: conditioners, shampoos, solid bars, creams, lotions, body butters, balms.

  • Usage: usually up to 15%.


Hair Care Formulations (Conditioners and Styling)


New Hair Style and Maintenance

New hair style:

  • Increase or decrease volume, straightness, curliness.

  • In straight hair, volume and alignment are inversely related; however, some polymers can increase fiber diameter.

  • In textured hair, volume is dependent on hair curvature.

  • Enhancing lubricity and/or glueing hair fibers in a new position.

Maintaining a hair style:

  • Prevent the uptake of moisture from the atmosphere.


Hair Styling

  • Polymers – used in styling gels, foams, mousses, lotions, creams, and finishing sprays.

  • Type, combination, and concentration of polymers define level of hold and stickiness.

  • Polymer films may be brittle and tough or plastic and soft.

  • Plasticizers (polyols, surfactants) can adjust product finish.

  • The stronger the hold, the more water resistance matters.

  • Volatile organic solvents may be required.

  • Oils and waxes – provide lubrication, smoothness, and water impermeability, particularly useful in textured hair.

  • Powders – provide matte appearance and enhance grip by increasing friction.


Conditioners: Purpose and Overview

  • Sebum is a natural and effective 'conditioner', but constant removal by washing and rubbing means consumers need extrinsic compounds.

  • Conditioners are used for:

    • Increasing smoothness.

    • Easier wet and dry combing.

    • Reducing static electricity.

    • Adjusting volume and improving texture.

  • Incorporating conditioning agents into shampoo formulations can significantly enhance performance.


Rinse-Off vs Leave-On Conditioners

  • Rinse-off conditioners: deliver intensive care through concentrated formulas for short-term contact; rich texture penetrates deeply during brief application; washes away cleanly without residue.

  • Leave-on formulations: feature lighter molecular weights and specialized dispersing agents that prevent buildup; provide continuous protection against environmental stressors while maintaining optimal moisture levels.

  • Choice depends on hair porosity and structure:

    • Fine hair benefits from lightweight leave-on sprays.

    • Thick or coarse textures may require both (rinse-off for deep nourishment, leave-on for ongoing care).

  • For straight, fine strands: light plant-derived esters with hydrolyzed proteins create effective products that don't weigh hair down.

  • Wavy and curly patterns: balanced formulas with panthenol and botanical extracts (aloe vera) enhance natural curl definition while maintaining moisture balance.

  • Tightly coiled/textured hair: rich butters combined with hyaluronic acid provide deep nourishment.


Common Conditioning Agents

  1. Cationic polymers (e.g., polyquaterniums): positively charged, adhere to negatively charged hair shaft, offer detangling, static control, and improved combability without interacting negatively with anionic surfactants.

  2. Silicones: impart smoothness, shine, and manageability by forming thin layer around hair shaft, reducing friction and providing protection; most widely used is dimethicone.

  3. Fatty alcohols (cetyl, stearyl, cetearyl alcohol): improve texture and spreadability while providing conditioning and emollient properties.

  4. Natural oils and butters (argan oil, coconut oil, shea butter, jojoba oil): help replenish lost lipids, nourish, hydrate, and improve overall hair health.


Cationic Surfactants

  • Carry positive charges in aqueous medium, easily adsorbing to negatively charged wet hair.

  • Mainly used in rinse-off formats.

  • Quaternary ammonium compounds (quats) often have preservation-boosting properties.

  • Potentially the most irritant surfactants.

  • Form primary emulsifier for the conditioner, creating an emulsion.

  • Quats represent the vast majority of this class.

  • Concentration of these ingredients (typically 3–6%) significantly impacts conditioning level.

  • Higher concentrations provide more intense conditioning but can lead to build-up or heavier feel, especially on fine hair.


Quaternary Ammonium Compounds

  • (Title slide – limited content)


Polyquaterniums

  • Cationic polymers that adsorb to wet hair via electrostatic attraction.

  • Molecular weight and charge density define properties:

    • High molecular weight increases product viscosity.

    • Low molecular weight increases hair adsorption.

    • Higher charge density increases hair adsorption.

  • Some modern versions ("ester quats") incorporate ester linkages, improving biodegradability and gentleness compared to traditional quats.


Fatty Alcohols and Rheology Modifiers

  • Fatty alcohols work synergistically with cationic surfactants to form stable lamellar gel network (key for emulsion stability and viscosity).

  • Contribute to emulsion structure, provide body, enhance rich creamy texture, add conditioning feel and lubrication.

  • Ratio of fatty alcohols to cationic surfactants is critical for optimal viscosity and stability.

  • Typically, a ratio of 1:1 or slightly higher fatty alcohol yields desirable creamy texture.

  • Rheology modifiers (natural gums, synthetic polymers) create optimal viscosity profiles while ensuring proper ingredient distribution.


Sensory Emollients – Oils and Silicones

  • Sebum and 18-MEA make hair partially hydrophobic, especially if undamaged.

  • Hydrophobic conditioners are attracted to hydrophobic parts of hair; provide lubrication, enhance shine, contribute to softness, help replenish lost lipids.

  • This category includes:

    • Various plant-derived oils (argan, jojoba, coconut).

    • Natural butters (shea, mango).

    • Synthetic or naturally-derived esters.

    • Silicones: dimethicone, dimethiconol, amodimethicone (additional electrostatic attraction in acidic conditions).

  • Reactive silicones can form long-lasting films after deposition.

  • Selective deposition on damaged hair; better conditioning efficiency; lower buildup than dimethicone; common in premium conditioners.

  • Total emollient phase: ~5%–25%, adjusting based on desired richness.


Key Mechanisms of Action and Role of pH

3 deposition mechanisms:

  1. Primary adsorption: cationic surfactants create positive charge density that bonds with damaged keratin sites; forms stable layers of amino acids and conditioning agents.

  2. Secondary mechanisms: oil phase components and specialized polymers; when properly emulsified, create structured lamellar networks that deposit during rinse phase; cationic guar gum enhances this process.

  3. Quaternary deposition: dilution-triggered release of conditioning agents; as water dilutes formulation, previously solubilized ingredients precipitate onto fiber surface.

Role of pH:

  • Finished pH of conditioner is critical for hair health.

  • Acidic pH (typically 3.5–5.0) helps close hair cuticles, leading to smoother, shinier hair and reducing frizz.

  • Cooling rates between 0.5–2°C per minute optimize development of lamellar structures.


Hair Conditioner Formulations – Manufacturing

Manufacturing process:

  1. Add 90% of water and cetrimonium chloride to main vessel; heat to 70–75°C.

  2. Melt cetearyl alcohol in jacketed side vessel; heat to 70–75°C.

  3. When both phases at 70–75°C, add oil phase to water phase with homogenization to form emulsion.

  4. When emulsion has formed, commence cooling to 40°C with paddle stirring only.

  5. Dissolve preservative in portion of reserved water; add to main vessel with continuous mixing.

  6. Add color to main vessel; continue cooling.

  7. Add fragrance; mix until homogeneous.

  8. Adjust pH with citric acid dissolved in water to pH 3.0–5.0.

  9. Cool to 35°C.

Typical Hair Conditioner Formulation (% w/w):

  • Cetrimonium chloride (CTAC) 30% active: 3.00%

  • Cetearyl alcohol: 2.80%

  • Perfume: q.s.

  • Preservative: q.s.

  • Citric acid: pH 3.0–5.0

  • Color: q.s.

  • Water (deionized): to 100.00%


Testing Conditioners – Combing, Static, and Gloss

  • Test swatches of hair can be assessed in-vitro to determine effect on combing.

  • A comb with a spring gauge measures resistance to combing; method can be used in-vivo without modification.

  • Effect on static electrification of dry hair can be assessed using a charge locator (valve voltmeter with probe connected to grid).

  • Greater bias of grid = larger charges affecting probe; measurements can be in-vitro or in-vivo.

  • Gloss/lustre can be quantified by scientific instrument in-vitro; in-vivo measurements are more difficult as perception of gloss accounts for both reflected and scattered light.


Stability Testing


Why Test Stability?

  • Stability: the ability of a cosmetic product to resist change of its initial properties over time under reasonably foreseeable or stated conditions of storage and use.

  • Looks at how product quality varies with time under influence of intrinsic and extrinsic factors.

  • Stability studies test parameters susceptible to change that influence quality, safety, and efficacy.

  • It is a company's responsibility to ensure the product put on the market is safe when used as directed.


Information Gained from Stability Testing

  • Predicted product shelf-life.

  • Recommended storage conditions.

  • Length of time product is expected to maintain quality.

Types of stability considered:

  • Physical: original physical characteristics should not change (viscosity, look, smell).

  • Chemical: ingredient chemistry and composition should not be altered; remain within limits if applicable.

  • Microbiological: preservative systems, GMP, and appropriate packaging should ensure microbial growth limits are not exceeded.

  • Functional: product attributes should not change, in line with product claims.

  • Safety: mandatory by regulation.


Intrinsic and Extrinsic Factors

Intrinsic factors:

  • Physical stability: solubility, precipitation, polarity, phase separation, cohesion.

  • Chemical stability: pH, chemical reactions, adsorption.

Extrinsic factors:

  • Time, temperature, radiation, oxygen, humidity, packaging material, microbial growth, vibration.


Shelf-Life

  • Shelf-life: time period during which product is expected to remain within approved specifications when stored in conditions defined on the label.

  • Release specifications (Quality Control): acceptance criteria defining product at time of release to market.

  • Shelf-life specifications (Product Development and Stability Testing): acceptance criteria product should meet throughout its shelf-life.

  • Shelf-life for commercial personal care product is normally 2–3 years and ~6 months once open.

Required label information:

  • Name and function of product.

  • Name/address of responsible person.

  • Nominal value.

  • Expiration date ("Best before" or preceded by symbol).

  • If expiration date >30 months, may not be reported; PAO (Period After Opening) must be reported with small jar symbol followed by period.

  • Particular cautions for use.

  • Batch number.

  • Ingredient list.


Period After Opening (PAO)

  • Defines the authorized period a product may be used after opening without harm to consumer.

  • PAO must be indicated for products with shelf-life over 30 months.

  • Products with shelf-life of 30 months or less must state an expiry date.

PAO not required for:

  • Single-use formats.

  • Pressurized-container aerosols.

  • Products where microbial growth is virtually impossible (e.g., high concentration of ethanol).

No formal way to define PAO – depends on:

  • Stability testing data.

  • Type of packaging.

  • How consumer interacts with product.

  • How product is often stored.

  • Where product is applied.


New Zealand Regulations for Stability

  • Regulations fall under EPA and Ministry of Health.

  • No general legal requirement for formal GMP certification (unlike EU's ISO 22716).

  • General guidelines include adherence to GMP, ingredient safety, stability testing, and labeling requirements.

  • In practice, many NZ brands voluntarily follow cosmetic GMP principles; retailers/distributors may require it; insurers may expect evidence of quality systems; export markets (EU, ASEAN, GCC) effectively force GMP compliance.


Early Signs of Instability

  • Changes in color, texture, fragrance, and separation of ingredients.


Signs of Instability – Emulsion and Contamination

  • Emulsion breakdown: if product recalled because emulsion has broken down, investigate distribution and whether supply chain routes face extreme temperatures/fluctuations during transport.

  • Bacterial contamination: don't immediately blame preservatives; production engineers should examine assembly line for contamination sources.

  • Preservative role: preservatives prevent contamination from consumer fingers; not meant to cover all microorganisms but target common ones (fungus, yeast, bacteria); test preservatives for ability to stick to jar walls – if they stick, they might not reach bulk of product.


Example – Vitamin C Serum Oxidation

  • Dermalure oxidation chart shows color progression from clear/light to dark amber.

  • Fully oxidized serum turns dark amber.

  • Do not use once color turns to dark amber.

  • Both serums are safe and effective until fully oxidized.


Formal Stability Testing

  • Stability should be tested in new products and whenever any product variable changes:

    • Packaging.

    • Ingredient supplier.

    • Ingredient trade name.

    • Formulation composition.

    • Manufacturing method.

    • Production equipment.

  • Product should be tested in final container-closure system (formulation-packaging compatibility).

  • Product must be sealed as it would be in market; all primary packing components included (container, lids, pumps, labels); ideally secondary packaging also included.


Types of Stability Testing

  • Long-term stability: should last for at least the expected product shelf-life or 5 years.

  • Accelerated stability: helps provide shelf-life information in short time by accelerating "normal" storage conditions.

  • Stress stability: helps formulator quickly assess how robust the product is during formulation development.

Example testing schedule:

  • Initial time point.

  • After 1 month.

  • After 3 months, then every 3 months in 1st year.

  • Every 6 months in 2nd year.

  • Annually throughout proposed shelf-life period.

  • Usually stopped at 5 years.

Accelerated stability uses adverse conditions to predict/indicate likely stability – no guarantee but good indication.


Stability Testing by Product Type

  • Emulsions: all stability testing.

  • Oils/balms/sticks: all except microbial and mechanical.

  • Surfactants: all stability testing.

  • Powders: all except cold challenge, freeze/thaw, climate chamber, but include microbial.

Formal stability studies: a new product is opened for the 1st time at each testing time.

Formulation DevelopmentSubsequent stagesFinal Lab + Scale-up
Long-termXX
AcceleratedXX
StressX

Long-Term Stability Testing – Climatic Zones

  • (Title slide – diagram/content limited)


Long-Term Stability Testing – Climatic Zone Definitions

Climatic ZoneDefinitionCriteriaLong-term testing conditions
ITemperate climate≤15°C / ≤11 hPa21°C / 45% RH
IISubtropical/Mediterranean>15 to 22°C / >11 to 18 hPa25°C / 60% RH
IIIHot & dry>22°C / ≤15 hPa30°C / 35% RH
IVAHot & humid>22°C / >15 to 27 hPa30°C / 65% RH
IVBHot & very humid>22°C / >27 hPa30°C / 75% RH

Setting storage temperatures on packaging:

  • EU/UK: 20°C

  • Australia: 25°C

  • Tropical climates: 30°C


Accelerated Stability Testing

  • Done in a climate chamber.

  • Typical testing conditions: 40°C ± 2°C (ideally at 2–3 temperature points), 65% RH ± 5% RH.

Example schedule:

  • Initial time point.

  • After 1 month.

  • After 3 months.

  • After 6 months.

Approximately, 10°C rise in temperature doubles the rate of reactions.

  • The greater the "acceleration", the more likely product changes occur that would never occur in market conditions.

  • Fragile products may require lower temperatures, therefore longer periods of testing.

  • Excessive temperatures may no longer accelerate "normal" conditions.

  • Indicator of stability, but not of instability.


Elevated Humidity Tests

  • Although products may be affected by humidity, it is the role of the container closure system to protect them.

  • Formulation instability due to humidity indicates inadequate protection from packaging.

  • Elevated humidity tests assess:

    • Effect of humidity on packaging.

    • Barrier properties of container-closure system.

  • Elevated relative humidity is a test of the pack, not a direct test of the product.


Quantifying Stability Results

  • Many product specifications can be quantified; acceptable results must be within specification range (e.g., pH: 5.0–6.0; Methylparaben assay 95–105%).

  • When specifications are subjective, a scale of change from baseline is helpful:

    • 0: No observable change/Barely discernible change.

    • 1: Slight change.

    • 2: Distinct change.

    • 3: Marked change.

    • 4: Very marked change.

  • Examples: organoleptic properties, compact powder resilience (drop test).


Stress Stability Testing

  • A formulator's tool; no formal requirement – depends on company's product development strategy.

  • Informative to the formulator, but do not indicate shelf-life.

  • Focused on specific product parameters, not holistic stability.

  • Indicative of intrinsic stability of formulation – not used to assess final product's stability.

Types of stress tests:

  • Mechanical tests (vibration, accelerated gravity).

  • Cycling tests (temperature and humidity).

  • Freeze/thaw.

  • High temperatures.

  • Microbial challenge.

  • Xenon weathering (light).


Cycling Tests

  • Involve variation of temperature and humidity over days or weeks.

  • Can be more stressful than constant temperature/humidity because acceleration and deceleration of particles under Brownian motion creates chaos.

  • Effective test for products being sold in different climates.

  • Example: 24-hour cycles of 25°C and 45°C, or 5°C to 25°C.


Freeze/Thaw Tests

  • Subject products to extreme freezing followed by thawing at room temperature in 24-hour cycles.

  • Cycles include temperatures from -18°C to -30°C, followed by room temperature (25°C/30°C).

  • Ideal for assessing likelihood of cleansing products crystallizing or clouding and emulsions separating.

  • Conducted on solutions, emulsions (creams/lotions), liquids, and semi-solid products.

Results:

  • 5 cycles typically represent stability over 24 months.

  • 6 cycles usually indicate stability over 30 months.


Other Stress Tests

  • Vibrations: mimics transportation; shows physical stability of disperse systems and powders; tests over range of frequencies and amplitudes.

  • Accelerated gravity: centrifuge at 3000–4000 rpm (10–15 mins); tests accelerated phase separation in disperse systems.

  • High temperatures: 60–80°C; tests chemical stability.

  • Xenon weathering (light test): ~24h illumination at 765 W/m² (mimics sunlight); results may not be truly indicative.

  • Light cabinet: usually twelve 40W fluorescent lights, product kept at 30cm from light sources; relevant for products containing dyes (especially natural dyes); products in clear/translucent packaging should be tested.

Ideal for short time frames and/or to provide short-term indication of stability before running longer, more extensive tests.


Microbiological Analysis – Routine and Screening

  • Originating from production, filling, and consumer use, microbial contamination is a continuous concern.

Routine Microbiological Analysis:

  • Each batch must undergo regular testing before market release to detect potential pathogens (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans).

  • Goal: ensure pathogens are not detectable in 0.1 g or 0.1 ml of product.

Screening Tests:

  • Quick and semi-quantitative kits (dip-slides, plate counts) available for easy assessment of contamination levels.

  • Provide rapid results; can be used by personnel without extensive microbiological training.

Quantitative Tests:

  • Professional labs conduct precise bacterial, mold, and yeast counts.

  • Require sophisticated methods (direct colony counts, enrichment culturing).


Microbial Challenge – Ph. Eur. Method

Test organisms:

  • Bacteria: Pseudomonas aeruginosa, Staphylococcus aureus.

  • Fungi: Candida albicans, Aspergillus niger.

Acceptance Criteria (Log Reduction Values in CFU):

2 days7 days14 days28 days
Bacteria23-NI
Fungi--2NI

NI = no increase from previous contact time.


Microbial Challenge – ISO 11930:2019

Test organisms:

  • Bacteria: Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli.

  • Fungi: Candida albicans, Aspergillus brasiliensis.

Criteria A (product is protected):

  • Bacteria at T7: ≥3, at T14: ≥3 and NI, at T28: ≥3 and NI.

  • C. albicans at T14: ≥1, at T28: ≥1 and NI.

  • A. brasiliensis at T14: ≥0, at T28: ≥1 and NI.

Criteria B (product does not satisfy all requirements but risk is acceptable):

  • Bacteria at T14: ≥3, at T28: ≥3 and NI.

  • C. albicans at T14: ≥1, at T28: ≥1 and NI.

  • A. brasiliensis at T14: ≥0, at T28: ≥0 and NI.

Acceptable range of deviation: 0.5 log.


New Zealand Regulations – Additional Info

  • Good Manufacturing Practices (GMP): manufacturers expected to adhere to GMP guidelines ensuring consistent production and quality standards; includes stability testing protocols.

  • Ingredient Safety: ingredients must comply with EPA and other relevant authority regulations.

  • Stability Testing: manufacturers usually required to conduct stability testing to ensure safety, efficacy, and shelf-life.

  • Labeling Requirements: accurate and informative labeling including shelf-life, storage conditions, and precautions for use.

  • NZ doesn't have specific group standards for stability testing of personal care products and cosmetics.

  • However, NZ often aligns with international regulations (ISO, FDA, EU Cosmetic Regulation (EC) No 1223/2009).

  • Relevant resources: EPA (Buying, using and storing cosmetics and toiletries); Regulation (EC) No 1223/2009; Recall websites (Product Safety New Zealand, SGS United Kingdom).


Māori Perspective of Product Formulation


Māori Perspectives on Product Formulation

  • (Title slide – presenter and course information)


Antony Nihoniho (Ngāi Tahu / Ngāti Porou / Ngāti Pākehā)

  • Contact details and affiliations.

  • Ancestral connections: Ngāti Porou (Te Tai Rāwhiti), Ngāi Tahu (Te Wai Pounamu), Wales (Blaenau Ffestiniog), England (Derbyshire).


Māori Worldview Summary

  • Framed by whakapapa.

  • Whānau and whenua – identity grounded in familial relations, embedded in place identified by environmental features.

  • Intergenerational perspective – non-linear perspective on time; past, present, and future inform decision-making.

  • Wellbeing viewed holistically: social, economic, spiritual, and emotional are interconnected.


Mātauranga Māori

  • Worldview: holistic, interconnected (e.g., Te Whare Tapa Whā).


Whakapapa

  • Holism infers an interconnected relationship between all things: living and non-living, animate and inanimate, tangible and intangible.

  • Identity, life meaning, and purpose intrinsically connected to:

    • Atua (God).

    • Whānau (family).

    • Whenua (land).

  • Tupuna (ancestors) are connection points back to Atua; Whenua IS whānau.

  • Whenua contain connection points to tupuna and Atua.

  • Whānau: family and birth; Iwi: tribe and skeleton; Hapū: subtribe and pregnant; Whenua: land and placenta.


Mātauranga Māori as Indigenous Knowledge

  • Oral culture based on local knowledge systems, therefore has regional (tribal and family) variations.

  • Narratives hold principles, communicate values in memorable ways; use of multiple literary devices (poetic, metaphor, personification).

  • Holistic, antithetical to categorization – in contrast to highly compartmentalized Western approach.

  • Interconnectedness, interdependent relationships.

  • Perspectives of mātauranga Māori have been impacted by colonization – infers a need for revitalization.


Māori Values

  • Mauri: all animate and inanimate elements have a life force (energy).

  • Mana: esteem, self-worth; we inherit and enhance our mana from contributions to community.

  • Manaakitanga: to maintain and raise the mana of others; hospitality.

  • Kaitiakitanga: from creation narratives, the earth is our mother, the forest, sea, and animals are her children – infers responsibility to look after them and natural resources.

  • Rangatiratanga: self-determination.

  • Tapu and noa: binary – tapu = restricted, noa = safe; remove tapu by karakia, kai, wahine.

  • Rāhui: restriction, prohibition, unsafe.


Te Taiao: The Natural Environment

  • Māori cosmology based on diverse narratives of creation that differ from area to area.

  • Basic elements describe movements from stages of nothing, darkness to light; the separation of earth and sky and the emergence of life.

  • Atua personify realms that demand respect and encumber humanity with responsibility of care and protection (tuakana/teina – humanity is the 'younger sibling' of nature).

  • Vegetation, life forms, soil, minerals are considered to have agency; some now recognized in law with legal personality – not for exploitation but holding rights.


Te Urewera

  • Te Urewera is ancient and enduring, a fortress of nature, alive with history; a place of spiritual value with its own mana and mauri.

  • Te Urewera has an identity in and of itself, inspiring people to commit to its care.

Section 11 of Te Urewera Act 2014:

  1. Te Urewera is a legal entity and has all the rights, powers, duties, and liabilities of a legal person.

  2. Rights, powers, and duties must be exercised on behalf of Te Urewera by Te Urewera Board.


Te Awa Tupua (Whanganui River)

  • "Ko au te Awa, ko te Awa ko au: I'm the River and the River is me."

  • In 2017, Te Awa Tupua (Whanganui River Claims Settlement) Act was passed.

  • The Act declares Te Awa Tupua a legal person and establishes the office of Te Pou Tupua.

  • Te Kōpuka (river strategy group) established with 17 members including iwi, local government, commercial and recreational river users.


Taonga Tuku Iho: Treasure Handed Down

  • "Everywhere my ancestors went they preserved and handed down the knowledge they had gained since creation."

  • "This was always held to be a strict duty and was gone about very carefully and with much ceremony."

  • Teone Taare Tikao (1890).


Te Waipounamu and Ngāi Tahu

Mana whenua:

  • Holding responsibility for the mana of the land and occupants.

  • Authority: responsibility of care.

Ngāi Tahu:

  • Held mana whenua over greater part of Te Waipounamu since C18.

  • Made up of 18 papatipu rūnanga (communities) centered around marae.

  • Each rūnanga associated with a number of hapū (sub-tribes) – traditionally the primary social grouping, not iwi.


Ngāi Tahu Historical Context

  • 1844–1864: 99% of Ngāi Tahu land sold to Crown for cash and for marking out adequate reserves, schools, hospitals, and access to mahinga kai (food sources) – none of which were provided.

  • Ngāi Tahu ostracized politically, economically, socially; lost access to and transmission of cultural knowledge.

  • Claim launched in 1849 and pursued relentlessly for 7 generations.

  • 1986: Claim submitted to Waitangi Tribunal.

  • 1996: Te Rūnanga o Ngāi Tahu Act passed.

  • 1998: Ngāi Tahu Claim Settlement Act ($170m + 'bolt-ons').

  • 2024: $1.7 billion net worth.


Ngāi Tahu Taonga Plants

  • 55 native plants recognized under 1998 Ngāi Tahu Claims Settlement Act.

  • Plants valued by Southern Māori for housing raw material, clothing, food, musical instruments, fine perfume.

  • Harakeke (flax) – used for weaving.

  • Tī kōuka (cabbage tree) – used for weaving sandals, rain capes; roots pounded to release sugars to add taste to food.

  • Celmisia (mountain daisies) – used for adornments.

  • Hinau – berries soaked in water to lessen bitter taste, provide ingredient for bread.


Ngāi Tahu Taonga Plants – Traditional Uses

  • Karaka nuts: ground, carefully removing toxic poison, to make bread; trace of poison resulted in severe convulsions.

  • Tutu: poisonous but could be distilled to make drink, edible jelly, and ink for moko.

  • Kotukutuku (fuchsia tree): grows sweet berries; provided rare source of color blue; Māori girls painted their lips, youth painted their faces.

  • Horopito (pepper tree): provided relief from toothache and headaches by chewing leaves; contains 4 active antifungals and powerful antioxidants.

  • Koromiko (hebe): cured stomach aches and diarrhea.


Taramea (Wild Spaniard)

  • Exquisite fragrance, prized perfume.

  • Presented as gift, traded for food, ornaments, tools, or pounamu.

  • Found in remote areas of Southern Alps.

  • Taramea = 'spiny thing', prickly plant known to trampers and farmers as 'the wild Spaniard'.

  • Leaves harvested by hand; aromatic resin extracted, sometimes by warmth of fire.

  • Gum mixed with animal or vegetable oils, blended with scented plants.

  • Ngāi Tahu invested in research on how to grow plant and extract oil; Taramea Fragrance Ltd formed.


Maraeroa C – Ginseng Project

  • Māori land entity; land held by community.

  • North of North Island; remote, difficult access.

  • 75% agreement required from shareholders.

  • Forestry block; 30+ years to mature.

  • Partnership with Scion (Crown research institute).

  • Ginseng: plant root from China/Korea with medicinal qualities.

  • 8 years research and development.

  • High quality, top-end product.


Titoki – Traditional Use

  • Highly valued in Māori society.

  • Pulp of berry is edible.

  • Seed cultivated for its oil.

  • Oil used to anoint the head – highly tapu.

  • Often mixed with fats and oils from whales and sharks.

  • Worn around the neck in a 'kopa' or pouch.

  • Dried bird skin (e.g., toroa/albatross) soaked in oil, rolled, and worn around the neck.


Titoki – Timber and Oil

  • Became known by European settlers as NZ oak; timber used for coach building, tool handles.

  • Timber held in high regard by Māori; 'peka tōki' relates toughness of wood to a hardened leader or tribe.

  • Grows naturally in coastal and lowland forest around many parts of NZ.

  • Shiny black seed looks appealing but bitter tasting.

  • Oil extracted from seed by Māori for body perfume.


Titoki – Oil Extraction Method

  • Berries collected, placed in water, then trampled vigorously.

  • Pulp separates from seed.

  • Clean seeds pounded and crushed in harakeke (flax) woven vessels.

  • Sometimes heated with hot rocks.

  • Wrung by hand to extract oil.


Consultation

  • (Title slide)


Consultation – Mahaanui Kurataiao Ltd and Rūnanga

  • Ngāi Tūāhuriri Rūnanga.

  • Te Hapū o Ngāti Wheke Rūnanga.

  • Te Rūnanga o Koukourārata.

  • Ōnuku Rūnanga.

  • Wairewa Rūnanga.

  • Te Taumutu Rūnanga.


Transgender Cosmetic Science


Learning Objectives

  • Define: use accurate, current terminology for gender identity and gender-affirming care.

  • Describe: explain how testosterone and estrogen + anti-androgen therapy alter sebum, hair, barrier function, and pigmentation.

  • Identify: recognize skin conditions that disproportionately affect TGD individuals and post-surgical considerations for scar care.

  • Apply: translate physiology into evidence-based personal-care formulation choices (actives, vehicles, claims, sensory).

  • Critique: evaluate marketing claims aimed at TGD consumers against current evidence base and known gaps.


Key Statistics

  • 0.5–1.6% of adults in recent national surveys identify as transgender or gender-diverse; proportion is higher among adolescents and rising.

  • 1 in 11,900 (historic Netherlands data for transgender in genotypic men; 1 in 30,400 in genotypic women) – illustrates how older registry-based numbers under-count modern self-identification.

  • 16.7–33% of trans women in US city-level surveys reported receiving illicit silicone or filler injections – major dermatologic concern.


New Zealand Census Data

  • (Slide contains demographic data for census usually resident population aged 15 years and over)


Cisgender and Transgender Status by Identity

  • (Diagram showing census data for cisgender and transgender status level 2)


Why the Cosmetic Scientist is in this Conversation

  • Hormones rewrite skin in months: cross-sex hormones cause sebum, hair, hydration, and barrier properties to shift on a 4–12 month timescale – faster than most product reformulation cycles.

  • Routines change with identity: transmasculine youth often disengage from skincare (associating it with femininity) exactly when testosterone begins to drive new acne – a formulation/marketing problem, not a clinical one.

  • Hair removal is a cornerstone: facial hair elimination is consistently rated one of the most important – and most distressing – parts of feminizing transition; pre- and post-procedure care is a real product opportunity.

  • Surgical adjuncts and scar care: top surgery, vaginoplasty, and phalloplasty leave scars; silicone-based scar products, sun protection, and ingredients for hypertrophic scars are highly relevant.

  • Inclusion = safety: when mainstream products fail, consumers turn to unregulated alternatives (e.g., illicit injected fillers); good products with honest claims are a public-health intervention.


The Skin and Hair, on Hormones

  • What changes, when, and why – the physiology a formulator needs.


Recap: How Androgens Drive the Pilosebaceous Unit

  • Adrenal and gonadal androgens (DHEA-S, androstenedione, testosterone) reach skin via blood.

  • 5α-reductase in sebocytes and dermal papilla → DHT (more potent androgen).

  • DHT binds androgen receptor on sebocytes, dermal papilla cells, sweat glands.

  • Results: ↑ sebum output, ↑ terminal hair on face/chest/abdomen, ↑ scalp follicle miniaturization in genetically susceptible sites.

Why this matters:

  • Adding testosterone moves a person along same axis as endogenous puberty – more sebum, more terminal hair, scalp thinning.

  • Adding estrogen + anti-androgen moves them the other way.

  • Same biology serves many consumers: PCOS, perimenopause, prostate-cancer anti-androgen therapy, hypogonadism, anabolic steroid use.

  • Sebum and acne shift in weeks; alopecia in years – product strategy should match timescale of change.

  • Androgens unmask (do not create) follicle responsiveness; family history predicts who develops AGA on testosterone.


Testosterone in Trans Men: Acne is the Story

  • Onset: 4–6 months after starting testosterone, peaking around 6 months.

  • Distribution: face, chest, back; truncal acne climbs most steeply.

  • Severity: usually mild-moderate; ~50% use a topical product within year 1.

  • Many trans men remain on testosterone indefinitely – management must be sustainable, not a 12-week course.

  • Severe/nodulocystic cases can respond to oral isotretinoin with usual cautions.


Hair: Gain at the Periphery, Loss at the Crown

Body and facial hair (desired):

  • 100% of trans men in Wierckx (2014) reported increased facial and body hair on testosterone undecanoate.

  • Ferriman-Gallwey ≥8 (clinical hirsutism range) reached by 80% at 12 months.

  • Hair shaft diameter approaches but does not always match cisgender male values within a year – longer exposure may be needed.

  • Product perspective: shaving, beard care, ingrown-hair management, post-shave irritation become 1st-time concerns.

Scalp/androgenic alopecia (often unwanted):

  • 31% had moderate-severe AGA after mean of 10 years on testosterone.

  • Older age and family history are strongest predictors.

  • Topical minoxidil + low-level laser light therapy (LLLT) are FDA-approved options that do not interfere with masculinization.

  • Finasteride is effective but blocks 5α-reductase (same enzyme driving beard growth) – often only considered after several years.

  • Some trans men welcome male-pattern hairline; others find it distressing – ask, do not assume.


Estrogen + Anti-Androgen: Changes for Trans Women

Typical regimens (know names, not doses):

  • Estrogen: 17β-estradiol valerate (oral) or transdermal estradiol patches; transdermal is less thrombogenic.

  • Anti-androgens: spironolactone (US), cyproterone acetate (Europe), GnRH analogues, occasionally finasteride.

  • In NZ/Australia: Spiractin, Aldactone, Spirotone.

  • Adjuncts in skincare context: topical 5α-reductase inhibitors not standard of care; eflornithine (Vaniqua) HCl 13.9% reduces facial hair growth but causes acneform reactions in 10–20%.

What the skin does:

  • Sebum: drops sharply by ~4 months; remains low at 12 months; existing acne usually improves.

  • Hydration/barrier: reduced sebum → drier skin, occasional brittle nails; eczema-prone skin can flare.

  • Body hair: hair-shaft diameter on legs, abdomen, cheeks falls within ~4 months; growth rate slows more gradually.

  • Beard: resists androgen suppression – usually requires laser, electrolysis, or eflornithine.

  • Pigment/cancer risk: some HRT data suggest modestly raised cutaneous melanoma risk; routine full-body checks recommended.


At-a-Glance: The Directions of Change

Skin/hair featureTrans men (testosterone)Trans women (estrogen + anti-androgen)
Sebum↑↑ Increases↓↓ Decreases sharply (~4 mo)
Acne↑↑ Frequently new or worse↓ Generally improves
Body & facial hair (off-scalp)↑↑ More terminal hair↓ Thinner shaft, slower growth
Beard specifically↑↑ Develops over yearsResistant – usually needs laser/electrolysis
Scalp hair↓ Risk of male-pattern AGA↓ Possible mild thinning if started later
Skin hydration/barrierOften oilier, occasional folliculitisOften drier; xerosis, brittle nails
Skin-cancer surveillanceStandard checks; remember chest tissue post-mastectomyRoutine full-body checks; HRT-melanoma data conflicting

What Young Consumers Say About Their Skin

(Free-text responses from 2021 Seattle survey of 118 adolescents – Covelli et al., paraphrased)

  • Trans man, 16: "I do not always do skin care because it is seen as a traditionally feminine thing and it can make me dysphoric." (Engagement gap)

  • Trans man, 19: "Ever since starting hormones my acne got worse so I needed to start using face wash." (Cue to enter category)

  • Cisgender female, 15: "I feel a greater pressure to keep my skin clean and clear. If my skin is more blotchy I feel worse about myself." (Common ground)

  • Trans woman, 16: "Girls and women are expected to take better care of their appearance than men to fit society's ideal standard." (Marketing pressure)


Translating Physiology into Formulation

  • (Section header slide)


5 Principles Before Any Specific Formula

  1. Formulate for physiology, not identity: an anti-androgen-affected sebaceous gland behaves the same in a trans woman and a man on prostate-cancer therapy; group by skin state, not gender label.

  2. Tolerance over potency, especially early: hormone-driven shifts coincide with high stress and frequent procedural disruption; gentle, redundant routines beat aggressive single-active stacks.

  3. Multifunctional, sustainable rituals: many TGD consumers will be on hormones for years to decades; twice-a-week 'reset' actives outperform 12-week 'courses'.

  4. Inclusive sensory and packaging: scent, color, font, claim language, and aisle all carry gender signals; make defaults neutral; offer customization.

  5. Honest claims, professional referral: cosmetic claims must not promise medical or surgical outcomes; build referral pathways into education.


Toolkit A: Skin on Testosterone (Oily, Acneic)

Product typeEvidence-based activesVehicle/format choicesNotes
Daily cleanserSalicylic acid 0.5–2%; gentle non-ionic surfactants (APGs, amphoteric blends)Gel or low-foam wash; pH <5.5; avoid harsh sulfatesFrequent over-washing common in newly acneic users – counsel via packaging copy
Truncal cleanserSalicylic acid 2% in long-contact wash; benzoyl peroxide 2.5–5% washLarger format, easy-grip; back-applicator toolsTruncal acne disproportionately affected – design for back/chest, not just face
Leave-on treatmentAdapalene 0.1%; azelaic acid 10–20%; niacinamide 4–10%Hydrating gel or light emulsion; sequential introductionAvoid stacking multiple actives at full strength early
Body lotion/leave-onSalicylic 2% lotion; urea 5–10%; niacinamidePump dispenser; quick-absorbing emulsion for full backA genuinely under-served format category
Beard/shave careGlycolic 5–8% post-shave toner; allantoin; panthenol; lipid mimeticsLight fluid; non-comedogenic; minimal scentPseudofolliculitis barbae and ingrowns are formulation territory
AGA supportTopical minoxidil 5%; caffeine; supportive scalp careFoam or solution; avoid heavy occlusionMarketed honestly – slows/partially reverses, not 'regrows'

Toolkit B: Skin on Estrogen + Anti-Androgen

Product typeEvidence-based activesVehicle/format choicesNotes
CleanserMild surfactants (APGs, betaines); glycerin-rich; minimal foamCream or milk cleansers; balm-to-oil for makeupSkin sebum may have dropped 50%+ from baseline – choose surfactants that do not strip further
Daily moisturizerGlycerin, hyaluronic acid, panthenol; ceramides 1/3/6-II; cholesterol; squalaneEmulsion (O/W) for daytime; richer (W/O or anhydrous) at nightReframe 'masculinizing' routine into barrier-supporting – same biology
Targeted treatmentsNiacinamide 4%; bakuchiol; peptides; retinoids if toleratedLow-irritation vehicles; buffer with moisturizerPrior eczema, perioral dermatitis flare common – go gentle
SunscreenBroad-spectrum SPF 30–50; hybrid mineral/chemical; tinted variantsDaily moisturizer-with-SPF and standalone formatsSome HRT data suggest modestly raised melanoma risk – make SPF effortless
Pre-laser/pre-electrolysis prepBland barrier moisturizer; SPF; avoid retinoids and AHAs 5–7 days pre-procedureEducation leaflet, sample sachetsA high-impact, low-friction product opportunity
Post-procedure soothePanthenol 5%; allantoin; centella asiatica; thermal water; zincSpray, gel, or thin emulsion; minimal preservation, sterile fill if possibleWindow of need: 24–72 h; positioning: 'recovery', not 'medical'
Body/nailUrea 5–10%; lactic acid 5%; biotin (limited evidence) for nailsBody lotion, hand cream, nail oilBrittle nails common with sebum drop – under-recognized

Hair Removal: Where Formulators Add Value

Electrolysis:

  • Permanent in skilled hands (~15–25% regrowth at 6 months).

  • Side effects: erythema, PIH, scarring, HSV reactivation.

  • Cosmetic-science angle: lidocaine creams, barrier creams, post-procedure soothing.

Laser and IPL:

  • Reduces, lightens, and thins hair; rarely permanent.

  • Best on dark hair/light skin; modern devices safer in deep skin tones.

  • Cosmetic-science angle: pre-treatment sun-avoidance education, post-treatment cooling and barrier products, pigment management with niacinamide/azelaic acid.

Topical eflornithine:

  • Reduces facial hair growth rate (FDA-approved).

  • Effect reversible; results visible after 6–8 weeks.

  • 10–20% develop acneiform reactions – formulator opportunity for compatible acne-tolerant moisturizer.


Sensory, Packaging, and Claims

Sensory:

  • Scent: keep neutral or omit – traditional 'masculine' or 'feminine' fragrances trigger dysphoria.

  • Color cosmetics: tints suitable across wider undertone range; concealer that covers beard shadow and post-laser pigment changes.

  • Texture: lighter on face (sebum-shifted, often acneic), richer on body (xerosis-prone).

Packaging:

  • Default to neutral, clinical, or ingredient-led design.

  • Refillable/decant systems support customization without re-formulation.

  • Clear typography; avoid gendered icons (pearls, beards) on primary packaging.

  • Sample sizes that match procedure-course duration (e.g., 4-week trials).

Claims:

  • Substantiate, then describe – never the other way around.

  • Avoid medical/surgical promises ('replaces breast augmentation', 'permanent hair removal').

  • If you list a TGD-relevant indication, ensure your panel included TGD users.

  • Provide referral pathways in pack/QR copy: WPATH, dermatology, plastic surgery.


Case Study: Post-Procedure Soothing Serum

The brief: Design a leave-on serum for 24–72 h window after laser hair removal, suitable for face and chest. Target: TGD adults and cisgender women undergoing repeated laser sessions. Must be tolerated alongside SPF and gentle cleanser; safe with darker skin tones; cosmetic claim only.

Active strategy:

  • 5% panthenol (barrier + soothing).

  • 0.2% bisabolol or 0.5% madecassoside (anti-inflammatory).

  • 2% niacinamide (PIH prevention).

  • Trace allantoin (keratolytic + soothing).

  • No retinoids, AHAs, BHAs, fragrance, or essential oils.

Vehicle and preservation:

  • Light O/W emulsion or hydrogel; 70–80% water phase.

  • Squalane + light esters as emollient.

  • Hyaluronic acid (high + low MW) for surface and depth.

  • Preservation: phenoxyethanol + ethylhexylglycerin; pH 5.0–5.5; no alcohol denat.

Claims and dossier:

  • Cosmetic claims: 'soothes', 'comforts', 'reduces visible redness', 'supports skin barrier'.

  • Substantiation: visual erythema scoring; TEWL recovery; user-perception study including TGD panelists.

  • Avoid: 'prevents pigmentation', 'medical-grade', 'heals'.

  • On-pack: 'compatible with laser and electrolysis aftercare'; QR to written instructions.


What We Still Do Not Know

  • Pediatric and adolescent data: most evidence from adult cohorts; hormone-treated adolescents may respond differently.

  • Comparative efficacy in TGD users: no head-to-head trials of standard acne or AGA actives specifically in TGD cohorts – extrapolate from cisgender data.

  • Skin-of-color outcomes: most cited surveys are predominantly white; pigment management, laser parameters, and PIH risk in skin of color need more work.

  • Long-term cancer signal: mixed melanoma and NMSC data with HRT; no long-term cohort focused on transfeminine populations.

  • Sensory and consumer research: few published packaging/sensory studies with TGD panels; industry has data, little is shared.

  • Real-world hair-removal aftercare: no comparative formulation trials of post-procedure cosmetics – cosmetic industry could lead here.


Ethics: The Boundaries of Cosmetic Care

  • Designing well-tolerated, evidence-based daily care.

  • Realistic, substantiated cosmetic claims.

  • Inclusive consumer research, panels, and sensory work.

  • Adjacent products to professional procedures (pre/post-laser, scar care, beard shadow camouflage).

  • Education materials with clear referral pathways.

  • Adverse-event monitoring with awareness of TGD-specific routes (e.g., hormone interactions).


5 Things to Take into the Lab

  1. Hormones rewrite skin in months – sebum, hair, and barrier shift on a 4–12 month timescale that does not match standard product cycles.

  2. Trans men gain acne and body hair, and may lose scalp hair; trans women gain dryness and reactive skin, and rarely lose facial hair without help.

  3. Most relevant actives are already familiar: salicylic acid, retinoids, niacinamide, ceramides, panthenol, minoxidil, silicone for scars, SPF every day.

  4. The product opportunity is rarely a 'trans range' – it is inclusive, hormone-aware design that quietly serves multiple consumer cohorts.

  5. Honest claims, neutral sensory, and named referral pathways are part of the formulation – not afterthoughts.

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