Spironolactone

INCI: SPIRONOLACTONE (INN)

CAS Number
52-01-7
Function
Anti-androgen (pharmaceutical); historically explored for anti-acne topical use
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Prescription drug (oral); not approved as an OTC cosmetic ingredient. FDA classifies topical spironolactone formulations as drugs, not cosmetics.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

๐Ÿšซ DO NOT USE IN COSMETICS. Annex II prohibited substance in EU. Anti-androgenic hormonal activity poses endocrine disruption risk. Any product containing this would be non-compliant under EC 1223/2009 and would likely trigger FDA drug classification in the US.

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Concern Level: High

Regulatory Flags

prop65 eu_banned_cosmetics eu_cosing_listed

Frequently Asked Questions

Is Spironolactone safe in cosmetics?

๐Ÿšซ DO NOT USE IN COSMETICS. Annex II prohibited substance in EU. Anti-androgenic hormonal activity poses endocrine disruption risk. Any product containing this would be non-compliant under EC 1223/2009 and would likely trigger FDA drug classification in the US. The EU classifies Spironolactone as "prohibited". Safety rating: POOR.

Is Spironolactone allowed in the EU?

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

What does Spironolactone do in cosmetics?

Spironolactone functions as: Anti-androgen (pharmaceutical); historically explored for anti-acne topical use. It is classified as a cosmetic ingredient in our database. CAS number: 52-01-7.

What is the Margin of Safety for Spironolactone?

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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