Ursodiol

INCI: URSODIOL

CAS Number
128-13-2
Function
Skin conditioning, skin protecting
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted for cosmetic use (note: also an FDA-approved pharmaceutical โ€” ursodeoxycholic acid โ€” for gallstone dissolution, but cosmetic use is separate and permitted)

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
moderate
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Primarily a pharmaceutical active (UDCA); cosmetic use is niche; dual-use ingredient โ€” ensure cosmetic claims do not cross into drug claims (especially in the US); ensure pharmaceutical-grade purity

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Concern Level: Low

Frequently Asked Questions

Is Ursodiol safe in cosmetics?

Primarily a pharmaceutical active (UDCA); cosmetic use is niche; dual-use ingredient โ€” ensure cosmetic claims do not cross into drug claims (especially in the US); ensure pharmaceutical-grade purity The EU classifies Ursodiol as "permitted". Safety rating: GOOD.

Is Ursodiol allowed in the EU?

Ursodiol EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Ursodiol do in cosmetics?

Ursodiol functions as: Skin conditioning, skin protecting. It is classified as a cosmetic ingredient in our database. CAS number: 128-13-2.

What is the Margin of Safety for Ursodiol?

adequate 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.

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