Hydrocortisone Acetate

INCI: HYDROCORTISONE ACETATE

CAS Number
50-03-3 (EC\# 200-004-4)
Function
Anti-inflammatory glucocorticoid
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status restricted
US Notes Classified as OTC drug active (21 CFR 348); inclusion in a cosmetic renders the product a drug under the FDCA. Not permitted as a cosmetic-only ingredient.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Prohibited in EU and restricted in US as a drug active. Chronic use causes skin atrophy, telangiectasia, striae, HPA axis suppression, and skin barrier damage. Cannot be legally marketed as a cosmetic in EU or US without drug approval.

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Concern Level: High

Frequently Asked Questions

Is Hydrocortisone Acetate safe in cosmetics?

Prohibited in EU and restricted in US as a drug active. Chronic use causes skin atrophy, telangiectasia, striae, HPA axis suppression, and skin barrier damage. Cannot be legally marketed as a cosmetic in EU or US without drug approval. The EU classifies Hydrocortisone Acetate as "prohibited". Safety rating: POOR.

Is Hydrocortisone Acetate allowed in the EU?

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

What does Hydrocortisone Acetate do in cosmetics?

Hydrocortisone Acetate functions as: Anti-inflammatory glucocorticoid. It is classified as a cosmetic ingredient in our database. CAS number: 50-03-3 (EC\# 200-004-4).

What is the Margin of Safety for Hydrocortisone Acetate?

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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