Gemfibrozil

INCI: GEMFIBROZIL

CAS Number
25812-30-0
Function
Pharmaceutical lipid-lowering agent (fibrate); not a conventional cosmetic functional ingredient
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status prohibited
US Notes Prohibited in cosmetics โ€” FDA classifies it as a drug (NDA-approved); inclusion in a cosmetic renders the product a drug under FD&C Act ยง201(g)

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Gemfibrozil is prohibited in cosmetics as an FDA-approved drug; California OEHHA flags cancer and reproductive toxicity concerns, with hepatotoxicity risk and GHS H302 classification; completely inappropriate as a standalone cosmetic ingredient.

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Concern Level: High

Regulatory Flags

prop65

Frequently Asked Questions

Is Gemfibrozil safe in cosmetics?

Gemfibrozil is prohibited in cosmetics as an FDA-approved drug; California OEHHA flags cancer and reproductive toxicity concerns, with hepatotoxicity risk and GHS H302 classification; completely inappropriate as a standalone cosmetic ingredient. The EU classifies Gemfibrozil as "prohibited". Safety rating: POOR.

Is Gemfibrozil allowed in the EU?

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

What does Gemfibrozil do in cosmetics?

Gemfibrozil functions as: Pharmaceutical lipid-lowering agent (fibrate); not a conventional cosmetic functional ingredient. It is classified as a cosmetic ingredient in our database. CAS number: 25812-30-0.

What is the Margin of Safety for Gemfibrozil?

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.

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