Ingredient Directory
High ConcernVegan Evaluator Flag

Adapalene

6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid

Safety Flags
CMR: Yes - Cat 2 (reproductive toxicity / teratogen)
Safety Notes

Third-generation synthetic retinoid; teratogenic - contraindicated in pregnancy; OTC only in the US at 0.1%; prescription-only in India, EU, Korea, Canada, Australia; causes photosensitivity.

Function & Common Use

Function

Retinoid / Keratolytic / Anti-acne (Drug only)

Category

Vitamins

Common In

Prescription/OTC acne gels and creams (Differin 0.1% gel)

Origin

Synthetic

Concentration Limits

India (CDSCO)

Not permitted in cosmetics; Schedule H prescription drug

EU Cosmetics Reg.

Not permitted as cosmetic ingredient in EU

US FDA (21 CFR)

0.1% OTC (Differin); higher concentrations Rx only

Korea (MFDS)

Not permitted in cosmetics; Rx prescription only

Format restriction: Pharmaceutical drug only; OTC at 0.1% in US only; prescription everywhere else; NOT a cosmetic ingredient

Baby restriction: Yes

Pregnancy: Yes

IFRA: No

Frequently Asked Questions

Is Adapalene safe to use in skincare?

Adapalene has a High concern rating. Third-generation synthetic retinoid; teratogenic - contraindicated in pregnancy; OTC only in the US at 0.1%; prescription-only in India, EU, Korea, Canada, Australia; causes photosensitivity.

Is Adapalene allowed in India?

Adapalene is currently classified as "Restricted - Prescription Only Drug (Schedule H)" under Indian cosmetics regulations. The maximum permitted concentration is Not permitted in cosmetics; Schedule H prescription drug.

What is Adapalene used for in cosmetics?

Adapalene functions as: Retinoid / Keratolytic / Anti-acne (Drug only). It is commonly found in: Prescription/OTC acne gels and creams (Differin 0.1% gel).

Can Adapalene cause an allergic reaction?

Yes. Adapalene has an allergen flag (No). If you have sensitive skin or known fragrance/contact allergies, patch-test products containing this ingredient before full use.

Is Adapalene safe for babies?

Adapalene has baby/child restrictions: Yes. Avoid using products containing this ingredient on infants unless specifically formulated and labelled for baby use.

TCS Assessment
High Concern
Data Confidence
High
Based on peer-reviewed safety data, regulatory status, and expert review by The Clean Sheet panel.

Regulatory Status

India (CDSCO)
Restricted - Prescription Only Drug (Schedule H)
EU
Not listed
US FDA
OTC Drug (0.1% - Differin); Rx for higher concentrations
Korea (MFDS)
Rx Only
Australia (TGA)
Prescription medicine (Schedule 4); not permitted in cosmetics
Canada (NHPID)
Prescription drug (DIN required); not a cosmetic ingredient

EU Annex: None

Identifiers

CAS106685-40-9
EC403-830-4

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