Claims & Evidence

Claims reference

Definitions, direct endpoints, evidence tiers and international control codes. Strategic reference — not a legal approval.

Reference content is provided in English, the language of the source dossier.

111 claims shown

Skin & Dermocosmetics — Barrier

Claim boundary · Demonstrate a functional or structural change in the stratum corneum. Hydration, occlusion and biological repair are not interchangeable.

Evidence architecture · Primary: one direct barrier endpoint selected in advance. Secondary: hydration, symptoms or imaging. Exploratory: lipids/proteins or microbiome. Preferred design: randomized within-subject or parallel control, controlled environment, prespecified time course and success rule.

  • Immediate hydration

    DirectC1

    Definition · Increases stratum-corneum hydration after one application.

    Direct endpoint · Corneometry vs baseline and vehicle/untreated control at the claimed time.

  • Long-lasting hydration

    DirectC1

    Definition · Maintains hydration above control through the claimed duration.

    Direct endpoint · Corneometry time course and area under the curve through the last claimed time.

  • Reduces transepidermal water loss

    DirectC1

    Definition · Decreases passive water loss from the skin under standardized conditions.

    Direct endpoint · TEWL change vs control after environmental acclimatization.

  • Strengthens the skin barrier

    DirectC2

    Definition · Improves resistance to a standardized barrier challenge.

    Direct endpoint · Lower post-challenge TEWL deterioration or better resistance vs control.

  • Accelerates barrier recovery

    DirectC2

    Definition · Shortens recovery toward the pre-challenge state after controlled disruption.

    Direct endpoint · Longitudinal TEWL recovery slope or time-to-recovery vs control.

  • Restores barrier lipids

    DirectC2

    Definition · Increases or normalizes directly measured stratum-corneum lipids.

    Direct endpoint · Targeted ceramide/lipid quantification in tape-strip samples.

  • Supports stratum-corneum integrity

    DirectC2

    Definition · Improves cohesion, desquamation or structural organization of the outer skin.

    Direct endpoint · Corneocyte image analysis, FTIR or other prespecified structural endpoint.

  • Supports microbiome balance

    SupportiveC2

    Definition · Maintains or shifts a prespecified microbial profile without an adverse imbalance.

    Direct endpoint · Absolute load plus compositional/diversity endpoints in a controlled longitudinal study.

Skin & Dermocosmetics — Aging

Claim boundary · Anchor claims in visible signs or direct mechanical measures. Dermal biomarkers can strengthen the story but do not replace product-level clinical evidence.

Evidence architecture · Primary: 3D wrinkle, mechanical or ultrasound parameter. Secondary: expert grading and consumer relevance. Exploratory: collagen, elastin, glycation or senescence markers. Preferred design: randomized controlled split-face or parallel study, standardized imaging, blinded analysis and duration matched to the biological ambition.

  • Reduces fine lines

    DirectC1

    Definition · Decreases a prespecified depth, length, area or volume metric for fine lines.

    Direct endpoint · 3D profilometry or calibrated image endpoint in a defined facial region.

  • Reduces the appearance of wrinkles

    DirectF1

    Definition · Improves a validated wrinkle score or image metric in the claimed region.

    Direct endpoint · Blinded expert grade or 3D wrinkle metric vs control.

  • Improves firmness

    DirectF1

    Definition · Increases resistance to controlled skin deformation.

    Direct endpoint · Prespecified cutometry or indentometry parameter.

  • Improves elasticity

    DirectF1

    Definition · Improves elastic recovery after controlled deformation.

    Direct endpoint · Prespecified cutometry elasticity parameter.

  • Improves dermal density

    DirectC2

    Definition · Changes a standardized ultrasound measure of dermal echogenicity/density.

    Direct endpoint · Blinded, co-registered ultrasound density measure.

  • Immediate plumping effect

    DirectC1

    Definition · Temporarily increases apparent volume or reduces surface depression.

    Direct endpoint · 3D volume/relief change at the claimed immediate time.

  • Supports collagen

    MechanisticC2

    Definition · Directly modulates collagen synthesis, deposition or degradation in a relevant model.

    Direct endpoint · Procollagen/collagen endpoint with viability and appropriate controls.

  • Helps protect against stress-induced aging signs

    SupportiveC2

    Definition · Reduces a defined damage marker after UV, pollution or oxidative stress.

    Direct endpoint · Prespecified damage marker vs stressed control plus a clinical bridge for visible claims.

Skin & Dermocosmetics — Sensitive skin

Claim boundary · Separate tolerability, perceived discomfort, visible redness and neuro-inflammatory mechanism. A questionnaire alone cannot prove a biological anti-inflammatory effect.

Evidence architecture · Primary: adverse-reaction incidence, erythema or symptom score according to wording. Secondary: TEWL, hydration and consumer comfort. Exploratory: neurogenic/inflammatory biomarkers. Preferred design: characterized sensitive-skin population, dermatologist supervision, controlled challenge where justified and blinded assessments.

  • Suitable for sensitive skin

    DirectC1

    Definition · Shows acceptable tolerability under normal use in a defined sensitive-skin population.

    Direct endpoint · Adverse reaction incidence/severity and dermatologist assessment.

  • Soothes immediately

    DirectC2

    Definition · Rapidly reduces warmth, stinging or discomfort after application.

    Direct endpoint · Prespecified symptom score vs control after a standardized challenge.

  • Reduces visible redness

    DirectC1

    Definition · Decreases instrumental or expert-assessed erythema.

    Direct endpoint · Mexametry/colorimetry or blinded erythema grading.

  • Reduces skin reactivity

    DirectC2

    Definition · Reduces the magnitude of response to a reproducible challenge.

    Direct endpoint · Post-challenge response area under the curve vs control.

  • Reduces tightness and discomfort

    DirectC1

    Definition · Reduces consumer-reported sensations without implying biological treatment.

    Direct endpoint · Validated patient/consumer score with an unbiased questionnaire.

  • Helps reduce cosmetic itch discomfort

    DirectC2

    Definition · Reduces itch sensation in a non-disease cosmetic population.

    Direct endpoint · Itch NRS/VAS and episode frequency under controlled use.

  • Post-procedure tolerance

    DirectMED

    Definition · Is well tolerated and improves comfort after a defined aesthetic procedure.

    Direct endpoint · Adverse events plus comfort/redness endpoint under standardized aftercare.

Skin & Dermocosmetics — Pigmentation

Claim boundary · Define the pigment target, calibrate color and include relevant skin tones. Avoid therapeutic “treats melasma” language and unqualified whitening promises.

Evidence architecture · Primary: lesion contrast, melanin index or colorimetric uniformity. Secondary: expert grading and consumer relevance. Exploratory: melanogenesis markers. Preferred design: 8–16 weeks where appropriate, controlled UV exposure/season, co-registered calibrated imaging and analyses by phototype.

  • Reduces the appearance of dark spots

    DirectF1

    Definition · Decreases spot contrast, area or intensity in a defined lesion type.

    Direct endpoint · Calibrated spot-to-surrounding-skin contrast or melanin index.

  • Evens skin tone

    DirectF1

    Definition · Reduces overall chromatic heterogeneity across predefined facial regions.

    Direct endpoint · Locked image-derived uniformity index.

  • Reduces visible hyperpigmentation

    DirectF1

    Definition · Decreases measured pigmentation for a clearly defined cosmetic condition.

    Direct endpoint · Melanin index, colorimetry or pigmented-area measure vs control.

  • Improves the appearance of melasma

    DirectMED

    Definition · Improves visible melasma severity without claiming disease treatment.

    Direct endpoint · Dermatologist mMASI/MASI plus standardized photography.

  • Fades the appearance of post-blemish marks

    DirectF1

    Definition · Reduces contrast or area of post-inflammatory marks.

    Direct endpoint · Lesion-level calibrated image/color analysis with new lesions tracked separately.

  • Brightens dull-looking skin

    DirectF1

    Definition · Increases visible radiance/luminance without necessarily reducing melanin.

    Direct endpoint · Calibrated luminance/gloss or blinded radiance grade.

  • Reduces the appearance of pigmented dark circles

    DirectF1

    Definition · Reduces the chromatic component of under-eye dark circles.

    Direct endpoint · Segmented color analysis separating pigment, vascular and shadow components.

Skin & Dermocosmetics — Aesthetics

Claim boundary · Keep cosmetic claims focused on appearance, comfort and measured surface/mechanical effects. Tissue healing and treatment claims trigger heightened or medical-device/drug review.

Evidence architecture · Primary: 3D geometry, color, surface or validated clinical grade. Secondary: comfort and consumer perception. Exploratory: barrier/biomarkers. Preferred design: controlled procedure parameters, standardized pose and imaging, comparator or split-area design, and clinically supervised follow-up.

  • Immediate tightening effect

    DirectC1

    Definition · Temporarily improves the appearance or measured mechanics of lax-looking skin.

    Direct endpoint · 3D displacement/angle or mechanical parameter at the claimed time.

  • Redefines facial contours

    DirectC2

    Definition · Improves a prespecified geometric contour metric.

    Direct endpoint · Co-registered 3D volume, angle or distance.

  • Reduces the appearance of under-eye bags

    DirectC1

    Definition · Decreases under-eye volume, area or clinical grade.

    Direct endpoint · 3D volume or blinded clinical grade at standardized time of day.

  • Refines pores and skin texture

    DirectC1

    Definition · Reduces visible pore area or surface irregularity.

    Direct endpoint · Locked image-analysis pore metric or 3D roughness.

  • Supports visible post-procedure recovery

    DirectMED

    Definition · Accelerates return of redness, dryness or discomfort toward baseline.

    Direct endpoint · Time-to-recovery for one prespecified sign.

  • Improves the appearance of mature scars

    DirectMED

    Definition · Changes color, relief or pliability of a defined mature scar.

    Direct endpoint · Validated scar scale plus color/3D surface measurement.

Hair & Scalp — Fiber performance

Claim boundary · Hair fiber is non-living material. “Repair” must describe measured structural, appearance or performance improvement, not biological regeneration.

Evidence architecture · Primary: mechanical, friction, combing, image or color endpoint matched to wording. Secondary: microscopy and consumer relevance. Preferred design: paired randomized tresses from multiple donors, standardized damage/dose/rinse, controlled humidity and hierarchical analysis.

  • Reduces hair breakage

    DirectC1

    Definition · Decreases broken fibers under standardized manipulation.

    Direct endpoint · Broken-fiber count or mass after repeated brushing.

  • Strengthens hair fibers

    DirectC1

    Definition · Increases force or energy to break, or reduces fragility.

    Direct endpoint · Single-fiber force–extension parameter with donor-level analysis.

  • Repairs damaged hair

    DirectC2

    Definition · Improves a directly measured property of damaged fibers; regeneration is not implied.

    Direct endpoint · Friction, breakage, protein loss or cuticle endpoint with two convergent measures.

  • Makes detangling easier

    DirectC1

    Definition · Reduces force, work or time required for wet/dry combing.

    Direct endpoint · Combing force/energy under standardized dose and rinse.

  • Controls frizz

    DirectC1

    Definition · Reduces halo area or flyaway fibers at defined humidity and time.

    Direct endpoint · Calibrated frizz image index in a climate chamber.

  • Defines and holds curls

    DirectC1

    Definition · Improves curl geometry, grouping and retention.

    Direct endpoint · Curl definition/elongation/retention after humidity or movement.

  • Increases shine

    DirectC1

    Definition · Increases specular reflection or blinded shine grade.

    Direct endpoint · Instrumental/image shine index under fixed geometry.

  • Protects from heat styling

    DirectC2

    Definition · Reduces damage caused by a defined thermal exposure.

    Direct endpoint · Retention of strength or reduced damage marker vs heat-only control.

  • Protects from chemical treatments

    DirectC2

    Definition · Reduces degradation after a defined color, bleach or relaxer process.

    Direct endpoint · Mechanical retention, protein loss or cuticle damage vs stress control.

  • Extends color vibrancy

    DirectC1

    Definition · Reduces color drift through claimed wash/exposure cycles.

    Direct endpoint · ΔE and L*a*b* components after standardized cycles.

Hair & Scalp — Growth

Claim boundary · Separate shedding, anchorage, growth rate, anagen ratio and new-hair count. Fiber or scalp evidence does not establish follicular growth.

Evidence architecture · Primary: prospectively selected hair-count, phototrichogram or growth-rate endpoint. Secondary: diameter, density and perception. Exploratory: follicle biomarkers/ex vivo growth. Preferred design: randomized placebo-controlled 3–6+ month study, tattooed/co-registered area, blinded reading, seasonal control.

  • Reduces hair shedding

    DirectF1

    Definition · Reduces the number of hairs lost over a defined period.

    Direct endpoint · Standardized shed count or phototrichogram vs placebo and seasonal baseline.

  • Improves hair anchorage

    DirectF1

    Definition · Increases extraction resistance or reduces detachable hairs.

    Direct endpoint · Validated extraction/anchorage measure plus shedding confirmation.

  • Increases hair growth rate

    DirectMED

    Definition · Increases elongation of existing identified hairs per unit time.

    Direct endpoint · Repeated macro-imaging of marked hairs in mm/day.

  • Promotes new hair growth

    DirectMED

    Definition · Increases newly visible hairs in a repeatedly imaged scalp area.

    Direct endpoint · Longitudinal new terminal-hair count in a tattooed area.

  • Extends the anagen phase

    DirectMED

    Definition · Increases the proportion of hairs in active growth.

    Direct endpoint · Anagen/telogen ratio by phototrichogram or trichogram.

  • Promotes ex vivo follicle growth

    MechanisticC2

    Definition · Increases isolated follicle elongation in culture; mechanistic only.

    Direct endpoint · Follicle elongation and viability across multiple donors.

Hair & Scalp — Density

Claim boundary · Density may arise from hair count, diameter, coverage or styling. Use wording that identifies the demonstrated mechanism.

Evidence architecture · Primary: hairs/cm², diameter, 2D/3D volume or scalp-visibility metric. Secondary: strength and perception. Preferred design: co-registered area, fixed styling/lighting and duration matched to a physical or biological mechanism.

  • Increases hair density

    DirectMED

    Definition · Increases the number of hairs per unit scalp area.

    Direct endpoint · Terminal and vellus hairs/cm² by phototrichogram.

  • Makes individual hairs thicker

    DirectF1

    Definition · Increases measured diameter of existing fibers.

    Direct endpoint · Hair diameter distribution by microscopy or calibrated imaging.

  • Makes hair look denser

    DirectC1

    Definition · Improves visible coverage regardless of cosmetic mechanism.

    Direct endpoint · Blinded coverage/scalp-visibility image score.

  • Increases hair volume

    DirectC1

    Definition · Increases the geometric envelope of the styled hair mass.

    Direct endpoint · 2D/3D hair volume at defined humidity and time.

  • Reduces visible scalp show-through

    DirectC1

    Definition · Decreases the proportion of scalp visible through hair.

    Direct endpoint · Locked scalp-pixel/hair-pixel ratio under standardized styling.

Hair & Scalp — Scalp biology

Claim boundary · Prove scalp benefits directly. Hair-fiber and sensory endpoints cannot substitute for scalp biological or follicular evidence.

Evidence architecture · Primary: flakes, sebum, hydration, TEWL, redness, pH or microbiome endpoint. Secondary: symptoms and acceptability. Preferred design: marked scalp area, standardized wash routine, controlled environment and product washout where needed.

  • Reduces visible flakes

    DirectF1

    Definition · Decreases visible scalp flake amount, area or severity.

    Direct endpoint · Standardized clinical grade or calibrated flake image analysis.

  • Controls excess scalp oil

    DirectC1

    Definition · Reduces sebum amount or rate of reappearance after washing.

    Direct endpoint · Sebumeter/Sebufix at a fixed post-wash interval.

  • Hydrates the scalp

    DirectC1

    Definition · Increases surface hydration without increasing greasy appearance.

    Direct endpoint · Site-adapted corneometry in a marked scalp window.

  • Strengthens the scalp barrier

    DirectC2

    Definition · Improves directly measured scalp barrier function.

    Direct endpoint · TEWL in standardized scalp windows, with hair density controlled.

  • Soothes a sensitive scalp

    DirectC2

    Definition · Reduces redness, stinging or discomfort in a defined sensitive population.

    Direct endpoint · Hierarchical redness and/or symptom endpoint.

  • Respects physiological scalp pH

    DirectC1

    Definition · Maintains or returns surface pH toward a predefined range.

    Direct endpoint · Calibrated scalp pH change under standardized washing.

  • Supports scalp microbiome balance

    SupportiveC2

    Definition · Maintains or shifts a prespecified microbial profile with relevant scalp outcomes.

    Direct endpoint · Absolute load plus compositional analysis linked to flakes/sebum/symptoms.

Hair & Scalp — Multi-ethnic hair

Claim boundary · Inclusivity is a validation design, not a biological claim about ethnicity. Describe measured curl pattern, diameter, color, practices and needs.

Evidence architecture · Primary: treatment effect within each prespecified texture/skin-tone stratum. Secondary: interaction and acceptability. Preferred design: stratified donors/panels, fit-for-texture handling protocols, adequate N per key stratum and transparent subgroup reporting.

  • Effective across the studied hair textures

    DirectC1

    Definition · Demonstrates performance separately across prespecified curl/diameter groups.

    Direct endpoint · Success within key strata and treatment-by-texture interaction.

  • Reduces breakage in tightly curled/coiled hair

    DirectC1

    Definition · Decreases rupture in high-curvature fibers under relevant handling.

    Direct endpoint · Breakage count plus mechanical testing across donors.

  • Eases detangling of textured hair

    DirectC1

    Definition · Reduces detangling force and time for defined textures.

    Direct endpoint · Combing energy and standardized detangling time.

  • Maintains curls in high humidity

    DirectC1

    Definition · Retains curl geometry and controls frizz at high relative humidity.

    Direct endpoint · Curl retention and frizz index at 85% RH.

  • Leaves no visible residue on dark hair/scalp

    DirectC1

    Definition · Avoids white or ashy residue on the studied colors/skin tones.

    Direct endpoint · Calibrated contrast/ΔE plus blinded residue grade.

Sun Care — SPF

Claim boundary · SPF primarily measures protection against UV-induced erythema. It does not mean total protection or unlimited extension of sun exposure.

Evidence architecture · Primary: market-accepted static SPF on the final formulation. Secondary: spectrum and photostability. Preferred design: required application dose, validated method, prespecified statistics and label category/rounding rules for each market.

  • SPF 30 / 50 / 50+

    DirectSUN

    Definition · States the labeled UVB/erythemal protection category.

    Direct endpoint · Market-recognized static SPF method and category thresholds.

  • UVB protection

    DirectSUN

    Definition · Reduces erythemally weighted UV exposure under standardized conditions.

    Direct endpoint · SPF matched to the exact label statement.

  • Very high protection

    DirectSUN

    Definition · Uses the highest protection category permitted by the target market.

    Direct endpoint · Measured SPF plus associated UVA criteria and local rounding rules.

  • Photostable protection

    DirectSUN

    Definition · Maintains spectral protection after a defined UV dose.

    Direct endpoint · Pre/post irradiation retention of UV absorbance or protection factor.

  • Immediate protection

    DirectSUN

    Definition · Provides the claimed protection without a waiting period.

    Direct endpoint · Performance measured at the claimed post-application time.

Sun Care — UVA

Claim boundary · UVA protection must be characterized separately from SPF. Broad-spectrum criteria and symbols differ by jurisdiction.

Evidence architecture · Primary: UVA-PF and/or critical wavelength as required locally. Secondary: long-UVA spectrum and photostability. Preferred design: current ISO or local method applied to final formula; lock substrate, irradiation and scaling rules.

  • UVA protection

    DirectSUN

    Definition · Reduces exposure to UVA radiation according to a defined protection factor.

    Direct endpoint · UVA-PF in vivo/in vitro under the applicable market framework.

  • Broad-spectrum UVA/UVB protection

    DirectSUN

    Definition · Meets the jurisdiction-specific combination of UVB and UVA criteria.

    Direct endpoint · SPF plus UVA-PF/critical-wavelength or local broad-spectrum test.

  • Long-UVA protection

    DirectSUN

    Definition · Attenuates a predefined long-UVA spectral band.

    Direct endpoint · Integrated transmittance/absorbance over the stated band.

  • Helps prevent signs of photoaging

    DirectSUN

    Definition · Reduces UV exposure and supports a demonstrated damage/visible-sign outcome.

    Direct endpoint · Compliant UVA/UVB protection plus a relevant damage or longitudinal clinical endpoint.

Sun Care — Water resistance

Claim boundary · Water resistance is measured after controlled immersion. It never means waterproof.

Evidence architecture · Primary: post-immersion SPF and retention under the local method. Secondary: UVA retention and film imaging. Preferred design: standardized immersion cycles, water conditions and pre/post testing; label the exact duration required locally.

  • Water resistant

    DirectSUN

    Definition · Retains sufficient protection after a standardized water-immersion procedure.

    Direct endpoint · Wet SPF and percentage retention under the target-market rule.

  • Very water resistant

    DirectSUN

    Definition · Retains performance after the more demanding locally defined immersion duration.

    Direct endpoint · Post-immersion SPF and local retention criterion.

  • Sweat resistant

    DirectSUN

    Definition · Retains film or protection after controlled sweating.

    Direct endpoint · Protection-factor retention or validated film coverage after sweat.

  • Sand and rub resistant

    DirectSUN

    Definition · Limits sand adhesion and/or protection loss under defined friction.

    Direct endpoint · Adhered sand mass or protection/film retention after standardized rubbing.

Sun Care — Visible light

Claim boundary · There is no visible-light SPF. Define the wavelength band, optical/biological endpoint and pigmentation-relevant population.

Evidence architecture · Primary: spectral transmittance/reflectance or induced-pigmentation endpoint. Secondary: mechanism and consumer acceptability. Preferred design: realistic film dose, calibrated light source, UVA contamination control, pigmented comparator and relevant skin tones.

  • Visible-light protection

    DirectF1

    Definition · Reduces transmission across an explicitly defined visible band.

    Direct endpoint · Integrated spectral transmittance/reflectance on a realistic product film.

  • Helps limit visible-light-induced pigmentation

    DirectF1

    Definition · Reduces a pigment response after controlled visible-light exposure.

    Direct endpoint · Longitudinal color/melanin change vs control in responsive phototypes.

  • Blue-light protection

    DirectF1

    Definition · Attenuates a defined blue spectral band; the term alone is ambiguous.

    Direct endpoint · Band-specific spectral transmission plus separate proof of any claimed benefit.

Sun Care — Inclusive photoprotection

Claim boundary · Demonstrate both protection and acceptability across diverse skin tones. Do not assume one pigment endpoint performs equally across all phototypes.

Evidence architecture · Primary: efficacy and/or cosmetic-acceptability success within prespecified tone strata. Secondary: reapplication, transfer and perception. Preferred design: objective skin-tone measurement plus stratified recruitment and calibrated imaging.

  • Tested across the studied phototypes

    DirectSUN

    Definition · Documents efficacy or acceptability separately in every included phototype stratum.

    Direct endpoint · Stratum-specific success and treatment-by-phototype interaction.

  • Invisible on the studied skin tones

    DirectC1

    Definition · Does not create a perceptible white cast at use dose.

    Direct endpoint · ΔE/luminance plus blinded grade across relevant tones.

  • No ashy finish on deeper skin tones

    DirectC1

    Definition · Avoids grey/ashy appearance on the studied deeper tones.

    Direct endpoint · Calibrated color change plus expert/consumer grade.

  • Helps protect skin prone to hyperpigmentation

    DirectSUN

    Definition · Combines UV/visible protection with evidence relevant to a pigment-prone population.

    Direct endpoint · Compliant sunscreen testing plus pigmentation endpoint where claimed.

  • Uniform protection after reapplication

    DirectSUN

    Definition · Maintains even film coverage and acceptable appearance over repeated applications.

    Direct endpoint · Film-uniformity imaging plus protection or validated proxy after cycles.

Beauty Tech & Innovation — Devices

Claim boundary · Validate metrology, cosmetic benefit and safety separately. Intended purpose and claims may trigger medical-device classification.

Evidence architecture · Primary: accuracy/repeatability or direct clinical benefit, depending on the claim. Secondary: usability/adherence. Preferred design: locked device/software version, reference method or sham control, multi-device/operator testing, worst-case settings and representative users.

  • Accurate measurement

    DirectTECH

    Definition · Produces results close to a traceable reference value.

    Direct endpoint · Bias, absolute error and limits of agreement across the use range.

  • Repeatable and reproducible measurement

    DirectTECH

    Definition · Produces consistent results within and across devices/operators.

    Direct endpoint · CV/ICC and variance components in a Gage R&R design.

  • Improves a skin or hair benefit

    DirectTECH

    Definition · The device directly improves a defined cosmetic outcome.

    Direct endpoint · Matched clinical/instrumental endpoint vs sham or control.

  • Personalizes the routine

    DirectTECH

    Definition · Uses device output to change selection, dose or routine and improve outcomes.

    Direct endpoint · Incremental benefit vs standard recommendation in a strategy trial.

  • Safe and well tolerated in use

    DirectTECH

    Definition · Shows acceptable adverse-event profile at claimed settings.

    Direct endpoint · Adverse-event incidence/severity and objective skin checks.

Beauty Tech & Innovation — Imaging

Claim boundary · An illustrative image is not automatically a measurement. Quantitative claims require calibrated acquisition, locked segmentation and analytical validation.

Evidence architecture · Primary: accuracy and repeatability of the image-derived metric. Secondary: sensitivity to change and expert agreement. Preferred design: independent validation dataset, standardized acquisition, co-registration and robust testing across skin tones/hair types.

  • Objective image quantification

    DirectTECH

    Definition · Converts images into a valid numerical measure of the target sign.

    Direct endpoint · Accuracy vs reference/annotation plus repeatability.

  • Detects subtle change

    DirectTECH

    Definition · Detects real longitudinal change above measurement noise.

    Direct endpoint · Smallest detectable change and signal-to-noise ratio.

  • 3D relief or volume measurement

    DirectTECH

    Definition · Quantifies topography, depth or volume from a 3D reconstruction.

    Direct endpoint · Geometric error, repeatability and target clinical metric.

  • Multi-zone mapping

    DirectTECH

    Definition · Spatially compares an optical biomarker or sign across defined regions.

    Direct endpoint · Regional stability, correction and prespecified summary metric.

  • Representative before/after images

    DirectC1

    Definition · Provides comparable illustrations without misleading selection or acquisition.

    Direct endpoint · Protocol compliance for camera, pose, light, distance and selection.

Beauty Tech & Innovation — AI-enabled assessment

Claim boundary · Validate the complete system: data, model, device, acquisition, output, population and intended use. Average performance can conceal material subgroup bias.

Evidence architecture · Primary: externally validated accuracy/calibration for the intended task. Secondary: repeatability, utility and user comprehension. Preferred design: frozen model, independent dataset, multi-expert truth, subgroup error analysis, failure handling, drift control and version traceability.

  • Reliable automated assessment

    DirectTECH

    Definition · Produces a score that agrees with an expert or instrumental reference.

    Direct endpoint · MAE/AUC/ICC with confidence intervals and prespecified thresholds.

  • Performance equivalent to an expert

    DirectMED

    Definition · Meets a justified non-inferiority margin for a narrowly defined task.

    Direct endpoint · Difference vs multiple experts under a prespecified non-inferiority design.

  • Equitable performance across studied skin tones

    DirectTECH

    Definition · Maintains acceptable accuracy and calibration in each tone group.

    Direct endpoint · Error, sensitivity and calibration by objectively measured tone stratum.

  • Sensitive to longitudinal change

    DirectTECH

    Definition · Correctly detects real change over repeated assessments.

    Direct endpoint · Responsiveness, SDC and agreement with a longitudinal reference.

  • Relevant personalized recommendations

    DirectMED

    Definition · Improves decisions or outcomes beyond a standard routine.

    Direct endpoint · Prospective decision-utility or incremental-benefit endpoint.

  • Instant result

    DirectC1

    Definition · Returns a valid output within the stated time at an acceptable failure rate.

    Direct endpoint · End-to-end latency, valid-output rate and stress testing.

Beauty Tech & Innovation — Translational models

Claim boundary · Mechanistic models explain and prioritize. Consumer claims need a direct bridge to the final product and human outcome.

Evidence architecture · Primary: one causal biomarker or tissue endpoint with viability and appropriate controls. Secondary: orthogonal validation. Exploratory: omics. Preferred design: multiple donors, within-donor randomization, realistic exposure, positive/negative controls, multiplicity control and a prespecified clinical bridge.

  • Mechanism of action demonstrated

    MechanisticC2

    Definition · Shows causal modulation of a relevant pathway in a defined model.

    Direct endpoint · Primary biomarker plus viability and pathway controls.

  • Efficacy in human ex vivo skin

    SupportiveC2

    Definition · Produces a directly measured effect in viable human explants.

    Direct endpoint · Normalized tissue endpoint localized by histology/imaging.

  • Predictive of clinical benefit

    TranslationalMED

    Definition · The model predicts direction or magnitude of an independent human outcome.

    Direct endpoint · Prediction performance on independent product/study data.

  • Protects against a defined stress

    SupportiveC2

    Definition · Reduces damage caused by a specified UV/pollution/oxidative challenge.

    Direct endpoint · Specific damage marker vs stressed control, with realistic exposure.

  • Omics signature associated with benefit

    ExploratoryC2

    Definition · Identifies a gene/protein signature associated with response.

    Direct endpoint · Prespecified or independently validated signature with FDR control.

Regulatory control codes

  • C1Routine cosmetic appearance/performance claim

    Usually cosmetic if wording stays on appearance, cleansing, conditioning or comfort and is directly substantiated.

  • C2Enhanced biological/repair claim

    Needs a strong product-level bridge; structure/function, inflammation, repair or microbiome wording may cross a regulatory boundary.

  • F1Market-specific functional/special claim

    Whitening/brightening, wrinkles, acne, hair-loss relief or similar benefits may require special/functional/quasi-drug pathways in some Asian markets.

  • SUNSunscreen-specific regulated claim

    SPF/UVA/water-resistance methods, permitted actives, label statements and product classification are market-specific.

  • TECHDevice/software performance claim

    Validate metrology and intended use; classification changes if the claim becomes diagnostic, therapeutic or affects body structure/function.

  • MEDHigh medical/therapeutic boundary risk

    Do not launch as a routine cosmetic claim without country-specific legal classification and an appropriate regulated pathway.

High-risk wording

  • Treats melasma, acne, eczema, psoriasis or dandruff disease

    Why it is high risk · Disease treatment/prevention; often drug, therapeutic or functional/special pathway.

    Safer wording · Improves the appearance of… / reduces visible flakes, only where locally acceptable.

    Evidence / pathway needed · Disease pathway or tightly qualified cosmetic evidence plus local legal review.

  • Stimulates hair growth / prevents hair loss

    Why it is high risk · Direct follicular or body-function claim; special/functional/quasi-drug/drug boundary.

    Safer wording · Reduces breakage; makes hair look fuller. Keep true growth claims in regulated pathways.

    Evidence / pathway needed · Long controlled follicular study and market-specific registration/approval.

  • Repairs skin / heals scars / regenerates tissue

    Why it is high risk · May imply modification of structure, healing or treatment.

    Safer wording · Supports barrier recovery; improves the appearance of mature scars.

    Evidence / pathway needed · Direct clinical evidence; procedure/device/drug classification review.

  • Boosts collagen / reverses aging

    Why it is high risk · Mechanistic or structure/function implication often exceeds finished-product evidence.

    Safer wording · Improves firmness or wrinkle appearance; supports collagen in a defined model.

    Evidence / pathway needed · Direct clinical endpoint plus qualified mechanistic bridge.

  • Dermatologist-level AI / diagnoses skin conditions

    Why it is high risk · Medical diagnostic intended purpose and high-performance representation.

    Safer wording · Automated cosmetic appearance assessment for a narrowly defined sign.

    Evidence / pathway needed · Medical-device/AI pathway or robust non-medical intended-use validation.

  • Clinically proven / clinically tested

    Why it is high risk · Can imply a strength or quality of evidence not actually delivered.

    Safer wording · Clinically tested to [specific result], with transparent footnote.

    Evidence / pathway needed · Adequate controlled clinical evidence matching the exact representation.

  • 100% protection / waterproof / sunblock

    Why it is high risk · Overstates sunscreen performance and conflicts with major-market rules.

    Safer wording · SPF/broad spectrum/water resistant for the locally permitted duration.

    Evidence / pathway needed · Market-recognized sunscreen tests and mandatory directions/warnings.

  • Works for all skin tones / all hair types

    Why it is high risk · Universal claim is rarely supported and may mask subgroup failure.

    Safer wording · Demonstrated across the studied tones/textures.

    Evidence / pathway needed · Adequate stratified samples and success in each stated group.