Ingredient Directory
Medium Concern Evaluator Flag

Squalene

All-trans-squalene (from shark or plant)

Safety Notes

Unsaturated triterpene; endogenous in sebum (~12%); skin-compatible; oxidises readily on air exposure forming oxidised squalene, comedogenic concern; shark-derived NOT vegan; plant-derived (olive/amaranth) vegan and preferred; note: squalane (hydrogenated) is more stable, squalene vs. squalane distinction important for claims

Function & Common Use

Function

Emollient / Antioxidant

Category

Emollient

Common In

Facial oils moisturisers (plant-sourced preferred)

Origin

Animal (shark liver) / Vegetable (olive/amaranth)

Concentration Limits

India (CDSCO)

No limit

EU Cosmetics Reg.

No limit

US FDA (21 CFR)

No specific 21 CFR cosmetic limit identified in source checked

Korea (MFDS)

No specific MFDS limit identified in source checked; verify if ingredient is used in a Korean functional cosmetic category

Pregnancy: No specific restriction identified in source checked; standard cosmetic use

Frequently Asked Questions

Is Squalene safe to use in skincare?

Squalene has a Medium concern rating. Unsaturated triterpene; endogenous in sebum (~12%); skin-compatible; oxidises readily on air exposure forming oxidised squalene, comedogenic concern; shark-derived NOT vegan; plant-derived (olive/amaranth) vegan and preferred; note: squalane (hydrogenated) is more stable, squalene vs. squalane distinction important for claims

Is Squalene allowed in India?

Squalene is currently classified as "Permitted" under Indian cosmetics regulations. No concentration limit is specified for India.

What is Squalene used for in cosmetics?

Squalene functions as: Emollient / Antioxidant. It is commonly found in: Facial oils moisturisers (plant-sourced preferred).

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

Regulatory Status

India (CDSCO)
Permitted
EU
Permitted
US FDA
Permitted
Korea (MFDS)
Permitted
Australia (TGA)
Cosmetic ingredient; standard TGA cosmetic framework applies; no therapeutic goods listing required unless therapeutic claims are made
Canada (NHPID)
Not specifically listed as restricted cosmetic ingredient in NHPID source checked; standard Health Canada cosmetic notification applies

Identifiers

CAS111-02-4
EC203-825-6

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