Ufiprazole

INCI: UFIPRAZOLE

CAS Number
73590-85-9
Function
Skin conditioning (per CosIng listing); chemically it is omeprazole sulfide (a pharmaceutical precursor/metabolite)
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Known as omeprazole sulfide/impurity C โ€” primarily a pharmaceutical substance; no cosmetic monograph; use in cosmetics may trigger FDA drug classification concerns

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Major red flag: This is omeprazole sulfide โ€” a PPI drug precursor/metabolite . Cosmetic use is extremely atypical and raises serious regulatory questions: (1) risk of drug-cosmetic boundary classification issues; (2) insufficient dermal safety data for cosmetic application; (3) potential systemic pharmacological activity; (4) may be challenged by Competent Authorities in EU and FDA. Not recommended for cosmetic formulation without extensive regulatory and toxicological justification.

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Concern Level: High

Frequently Asked Questions

Is Ufiprazole safe in cosmetics?

Major red flag: This is omeprazole sulfide โ€” a PPI drug precursor/metabolite . Cosmetic use is extremely atypical and raises serious regulatory questions: (1) risk of drug-cosmetic boundary classification issues; (2) insufficient dermal safety data for cosmetic application; (3) potential systemic pharmacological activity; (4) may be challenged by Competent Authorities in EU and FDA. Not recommended for cosmetic formulation without extensive regulatory and toxicological justification. The EU classifies Ufiprazole as "permitted". Safety rating: POOR.

Is Ufiprazole allowed in the EU?

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

What does Ufiprazole do in cosmetics?

Ufiprazole functions as: Skin conditioning (per CosIng listing); chemically it is omeprazole sulfide (a pharmaceutical precursor/metabolite). It is classified as a cosmetic ingredient in our database. CAS number: 73590-85-9.

What is the Margin of Safety for Ufiprazole?

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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