Is Tretinoin safe in cosmetics?
Tretinoin has a safety rating of "MODERATE" in our database. EU status: prohibited. US status: prohibited.
Moderate
Active Ingredient
Tretinoin
Also known as: ATRA, all-trans-Vitamin A acid, Atragen, Aberel, (all-E)-3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid (+14 more)
INCI: TRETINOIN
Tretinoin (CAS 302-79-4) is a cosmetic active ingredient functioning as Keratolytic; normalizes keratinization; accelerates cell turnover; stimulates. EU Regulation 1223/2009 status: prohibited. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.
View industrial chemical safety profile for CAS 302-79-4 →
Auto-generated CPSR Part A draft with source citations
Function
Keratolytic; normalizes keratinization; accelerates cell turnover; stimulates fibroblast collagen production. Used for atrophic acne scar treatment, photoaging, acne.
Safety Rating
MODERATE
Regulatory Status
EU EU Status
prohibited
US US Status
prohibited
US Notes
Prescription-only drug (Rx) in the US for acne and photoaging treatment. Not permitted in OTC cosmetics under FDA classification. Requires CDER approval as a new drug application. Used clinically at 0.025–0.1% for acne; 0.05% shown to improve atrophic acne scars.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Tretinoin.
Calculate MoS for your specific formulation with the MoS Calculator.
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| NOEC | =0.04 mg/L | Rat | environmental | short-term | ECOTOX |
| NOEC | =0.5 mg/L | Rat | environmental | short-term | ECOTOX |
| NOEC | =1.2 mg/L | Rat | environmental | short-term | ECOTOX |
| NOEC | =0.13 mg/L | Rat | environmental | short-term | ECOTOX |
| NOEC | =0.8 mg/L | Rat | environmental | short-term | ECOTOX |
| NOEC | =0.03 mg/L | Rat | environmental | short-term | ECOTOX |
| NOEC | =0.035 mg/L | Rat | environmental | short-term | ECOTOX |
| LOEL | =20 mg/kg-day | Mouse | oral | short-term | ECOTOX |
| LOEL | =30 mg/kg-day | Mouse | oral | short-term | ECOTOX |
| LOEL | =20 mg/kg-day | Mouse | oral | short-term | ECOTOX |
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 375
(EC) 2009/1223
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.
SA Saudi SFDA (II - Prohibited)
ASEAN Cosmetic Directive (II)
Ref: 375
BRIN Brazil/India Cosmetics
India: Prohibited (GNRAS)
Additional Jurisdictional Restrictions (10)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | banned | - | - |
| IN | banned | - | all cosmetics — classified as drug in India |
| IN | drug_classification | - | skin care products with retinoid effects |
| AU | restricted | - | prescription only |
| GCC | banned | - | All cosmetics |
| BR | banned | - | - |
| CA | banned | - | - |
| CA | restricted | 0% — prohibited as cosmetic ingredient | All cosmetics (drug only) |
Additional Ingredient Properties
3 property records from structured ingredient metadata.
pediatric_safety
{"safe_for_newborn_0_6m": "avoid", "safe_for_infant_6_12m": "avoid", "safe_for_toddler_1_3y": "avoid", "safe_for_child_3_12y": "avoid", "safe_for_teen_12_18y": "avoid", "pediatric_max_concentration_pct": "0.0", "adult_max_concentration_pct": "0.1", "pediatric_dermal_absorption_factor": "very high", "immature_skin_barrier_risk": "very high", "oral_ingestion_risk": "high", "eye_irritation_risk": "ve…
pregnancy_detail
{"pregnancy_safe": "no", "breastfeeding_safe": "no", "trimester_restriction": "all", "risk_category": "FDA-X", "reason": "Teratogenic; causes birth defects in high doses", "alternative_ingredient": "Azelaic Acid", "source": "ACOG; FDA; AAD"}
synergy
{"inci_name_2": "Azelaic Acid + Niacinamide", "synergy_type": "efficacy-boost", "synergy_description": "Prescription retinoid with antibacterial and anti-inflammatory for acne + PIH", "combined_benefit": "Maximum acne clearance, reduced PIH, comprehensive treatment, improved tolerance", "efficacy_multiplier": "3x", "mechanism_of_action": "Tretinoin normalizes keratinization; azelaic provides antib…
Function Categories & List Membership
Cosmetic/Chemical Function Categories
No specific technical function
Regulatory List Membership (3)
California Proposition 65 (OEHHA)
EU Banned in Cosmetics
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Tretinoin.
Regulatory Flags
rx-only
not-a-cosmetic-ingredient
eu-banned-in-cosmetics
teratogenic
scar-benchmark
post-epithelialization-only
pharmaceutical-reference
prop65
eu_banned_cosmetics
eu_cosing_listed
Known Synonyms
ATRA
all-trans-Vitamin A acid
Atragen
Aberel
(all-E)-3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid
Retinoic acid, all-trans-
all-trans-Retinoic acid
Acid A Vit (Belgium, Netherlands)
Aknefug
Alltrans-retinoic acid
all-trans-Vitamin A1 acid
15-Apo-beta-caroten-15-oic acid
BRN 2057223
3,7-Dimethyl-9-(2,6,6-trimethylcyclohex-1-enyl)nona-2,4,6,8-all-trans-tetraenoic acid
Effederm
EINECS 206-129-0
NSC-122758
beta-RA
Retin-A
Chemical Function
No specific technical function
Regulatory Lists
OEHHA Proposition 65 (3/2019)
OEHHA Proposition 65 (1/2023)
Personal care; Southeast Asia
pharmaceutical
pharmaceutical
pharmaceutical
pharmaceutical
pharmaceutical
Canada; pharmaceutical
Canada; pharmaceutical
Canada; pharmaceutical
banned; Europe; Personal care
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
TRETINOIN
ChEMBL ID
CHEMBL38
Max Phase
4
Adverse Event Associations
2774
Frequently Asked Questions
Is Tretinoin allowed in the EU?
Tretinoin EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does Tretinoin do in cosmetics?
Tretinoin functions as: Keratolytic; normalizes keratinization; accelerates cell turnover; stimulates fibroblast collagen production. Used for atrophic acne scar treatment, photoaging, acne.. It is classified as a Active Ingredient in our database. CAS number: 302-79-4.
Is Tretinoin used outside cosmetics?
Tretinoin also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Tretinoin 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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