Moderate Active Ingredient

Tretinoin

INCI: TRETINOIN

CAS Number
302-79-4
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 Status prohibited
🇺🇸 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 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
high
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Tretinoin (all-trans retinoic acid, CAS 302-79-4) is a prescription-only pharmaceutical in both the US and EU, not a cosmetic ingredient. Documented 0.05% tretinoin improves atrophic acne scars via normalized keratinization and accelerated cell turnover. Included in the database as a benchmark reference for formulators comparing cosmetic retinoid actives. EU: Prohibited in cosmetics. US: Prescription-only drug. Contraindicated in pregnancy due to teratogenic risk. Avoid application to open wounds.

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Concern Level: High

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

Frequently Asked Questions

Is Tretinoin safe in cosmetics?

Tretinoin (all-trans retinoic acid, CAS 302-79-4) is a prescription-only pharmaceutical in both the US and EU, not a cosmetic ingredient. Documented 0.05% tretinoin improves atrophic acne scars via normalized keratinization and accelerated cell turnover. Included in the database as a benchmark reference for formulators comparing cosmetic retinoid actives. EU: Prohibited in cosmetics. US: Prescription-only drug. Contraindicated in pregnancy due to teratogenic risk. Avoid application to open wounds. The EU classifies Tretinoin as "prohibited". Safety rating: MODERATE.

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.

What is the Margin of Safety for Tretinoin?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

Compliance Tools

Check Tretinoin compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
Check compliance across 55 jurisdictions
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
Compare limits across jurisdictions

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