Is Retinol safe in cosmetics?
Retinol has a safety rating of "MODERATE" in our database. EU status: restricted. US status: permitted.
Retinol
Also known as: All-trans retinol, Vitamin A, Retinol, all-trans-, 4-06-00-04133, Axerophtholum (+15 more)
INCI: RETINOL
Retinol (CAS 68-26-8) is a cosmetic active ingredient functioning as retinoid / skin-renewing / active. EU Regulation 1223/2009 status: restricted, max 0.05% RE in body lotions; 0.3% RE in other leave-on and rinse-off products. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 68-26-8 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Retinol is classified GHS Danger (H302, H317, H319, H360, H413) in the chemicals database but is restricted in EU cosmetics at max 0.05% RE in body lotions; 0.3% RE in other leave-on and rinse-off products.
Source: Cosmetics: ingredients.eu_status/eu_max; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
retinoid / skin-renewing / active
Safety Rating
MODERATE
Regulatory Status
EU EU Status
restricted
EU Max Conc.
0.05% RE in body lotions; 0.3% RE in other leave-on and rinse-off products
US US Status
permitted
US Notes
No federal concentration limits for retinol in OTC cosmetics. FDA classifies retinol as a cosmetic ingredient (not drug) at typical cosmetic use levels. No mandatory pregnancy or age warnings required under US law, unlike EU Regulation 2024/996. Safety guidance relies on industry self-regulation (CIR); CIR has affirmed retinol safe as used. Aggregate exposure concern (diet + supplements + topical) applies equally but is not regulated at federal level.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Retinol.
Calculate MoS for your specific formulation with the MoS Calculator.
Dermal Penetration Profile
Skin absorption and penetration characteristics of Retinol, relevant to systemic exposure and MoS calculations.
Absorption %
8-12%
Penetration Level
dermis
Penetration Depth
epidermis/dermis
Molecular Weight
286.5 Da
Log P
5.68
Systemic Absorption
yes
Topical Bioavailability
2-5%
Safety Margin Factor
high
Vehicle Dependent
Yes — absorption varies by formulation
Source: SCCS/1516/13, CIR
EPA ToxValDB — Toxicity Values
3 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LEL | >3000 mg/day | Human | oral | - | EFSA |
| LD50 | =1510 mg/kg | Mouse | oral | - | ChemIDplus |
| LD50 | =2000 mg/kg | Rat | oral | - | ChemIDplus |
Endocrine Disruptor Evidence (Expanded)
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
Cosmetic-Specific Mechanism
Category: other
Receptor targets: RAR (retinoic acid receptors), RXR
LOEC: 100 nM
EU status: restricted (max 0.3% face leave-on; max 0.05% body leave-on; EU 2024/996)
agonist (RAR/RXR – nuclear receptors)
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10 - 100 tonnes
Substance Type
SUBSTANCE; GROUP
SVHC Candidate
No
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
Additional Jurisdictional Restrictions (5)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | restricted | 0.3 | (a) Face products (b) Body products |
| AU | restricted | 0.3 | anti-aging products |
| AU | restricted | 0.05 | body lotions |
| SA | restricted | 0.3 | Leave-on and rinse-off products (non-body lotion) |
| UK | restricted | - | - |
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (2 records across 5 sources)
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| measured_in_vitro | 7.74 | In vitro — Franz diffusion cells | - | SCCS/1576/16; SCCS/1639/21; SCCS/1661/23 (2016) |
| measured_in_vitro | 10.0 | - | - | SCCS/1516/13, CIR |
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Face Cream | 0.01–0.3 | 1 | CIR/SCCS 2023 |
| Serum | 0.1–0.5 | 1 | CIR/SCCS 2023 |
| Body Lotion | 0.01–0.05 | 0.05 | CIR/SCCS 2023 |
Additional Ingredient Properties
10 property records from structured ingredient metadata.
acne
{"cas_number": "68-26-8", "anti_acne_mechanism": "keratolytic/comedolytic/anti_inflammatory", "comedogenicity_rating_0_to_5": "0", "acne_type_efficacy": "inflammatory/non_inflammatory", "p_acnes_mic_ug_per_ml": "No direct antibacterial", "sebum_reduction_pct_clinical": "8-12", "keratolytic_strength": "moderate", "exfoliation_mechanism": "chemical", "optimal_ph_for_efficacy": "5.5-6.5", "peel_depth…
anti_aging
{"anti_aging_claim": "anti-wrinkle, collagen-boosting, cell-turnover, brightening", "mechanism_of_action": "Converted to retinal then retinoic acid, stimulates collagen, normalizes keratinization", "target_skin_layer": "epidermis, upper dermis", "collagen_stimulation": "Yes - increases collagen I, III by 70-80%", "elastin_protection": "Moderate", "wrinkle_reduction_pct": "10-25", "clinical_study_d…
anti_pollution
{"cas_number": "68-26-8", "ingredient_class": "other", "primary_mechanism": "barrier_reinforcement", "pollution_types_targeted": "PM2_5", "IR_A_protection": "no", "visible_light_protection": "no", "digital_screen_protection_claim": "no", "PAH_neutralization": "no", "ozone_protection": "no", "mitochondrial_protection": "no", "Nrf2_activation": "no", "AhR_pathway_modulation": "no", "NF_kB_inhibition…
baby_pediatric
{"cas_number": "68-26-8", "ingredient_class": "other", "pediatric_safety_rating": "contraindicated", "minimum_age_months": "0", "neonatal_safe": "no", "premature_infant_safe": "no", "skin_barrier_maturity_consideration": "CONTRAINDICATED: Teratogenic, skin turnover unsuitable for baby skin", "transepidermal_absorption_risk_pediatric": "high", "systemic_exposure_concern_pediatric": "high", "dose_pe…
comedogenicity_detail
{"comedogenicity_rating": "0", "irritancy_rating": "3", "skin_type_suitability": "oily,combination,normal,acne-prone,mature", "acne_safe": "yes", "source": "Vitamin A - irritating initially"}
concentration
{"min_concentration_pct": "0.01", "max_concentration_pct": "0.1", "typical_concentration_pct": "0.05", "product_type": "Eye Cream", "function_at_concentration": "Anti-aging, cell turnover", "source": "CIR Safety Assessment; Supplier TDS"}
dermal_absorption
{"molecular_weight_da": "286.5", "log_p_value": "5.68", "skin_penetration_level": "dermis", "penetration_depth": "epidermis/dermis", "absorption_pct": "8-12", "systemic_absorption": "yes", "penetration_enhancer": "no", "occlusion_effect": "no", "vehicle_dependent": "yes", "skin_barrier_effect": "weakens", "bioavailability_topical_pct": "2-5", "safety_margin_factor": "high", "source": "SCCS/1516/13…
interactions
{"ingredient_2": "Air (oxygen)", "interaction_type": "destabilizing", "severity": "caution", "effect": "Oxidation of retinol, reduced potency", "recommendation": "Airless packaging or nitrogen flushing recommended", "data_source": "Formulation science literature, dermatological research, cosmetic chemistry best practices", "last_updated": "2026-03-05"}
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Flavouring and nutrient
Softener and conditioner
Regulatory List Membership (1)
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for Retinol.
Regulatory Flags
eu-restricted
sccs-opinion
pregnancy-warning
age-restriction
aggregate-exposure-concern
fda_food_additive
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 7.74 | In vitro — Franz diffusion cells | Gel and o/w emulsion |
| 10.0 | - | - |
Known Synonyms
All-trans retinol
Vitamin A
Retinol, all-trans-
4-06-00-04133
Axerophtholum
BRN 0403040
3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclchexen-1-yl)-2,4,6,8-nonatetraen-1-ol
3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraen-1-ol, (all-E)-
EINECS 200-683-7
Homagenets Aoral
Retrovitamin A
Sehkraft A
Super A
Vi-alpha; Vi-alpha
Vitamin A1 alcohol, all trans
Vitamine A
Vitaminum A
Vitavel-A
Wachstumsvitamin
Antixerophthalmisches Vitamin
Chemical Function
Softener and conditioner
Flavouring and nutrient
Regulatory Lists
pharmaceutical
Europe; supplements
Europe; food_additive; supplements
inert_ingredient; Pesticides
inert_ingredient; non_food_use; Pesticides
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
RETINOL
ChEMBL ID
CHEMBL986
Max Phase
4
Adverse Event Associations
1884
Frequently Asked Questions
Is Retinol allowed in the EU?
Retinol EU regulatory status: restricted. Maximum allowed concentration: 0.05% RE in body lotions; 0.3% RE in other leave-on and rinse-off products. This is based on EU Regulation 1223/2009 and its amendments.
What does Retinol do in cosmetics?
Retinol functions as: retinoid / skin-renewing / active. It is classified as a Active Ingredient in our database. CAS number: 68-26-8.
Is Retinol used outside cosmetics?
Retinol also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Retinol have different safety status in cosmetics vs industrial chemicals?
Retinol is classified GHS Danger (H302, H317, H319, H360, H413) in the chemicals database but is restricted in EU cosmetics at max 0.05% RE in body lotions; 0.3% RE in other leave-on and rinse-off products.
Compliance Tools
Check Retinol compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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