Hydroxycortisone Succinate

INCI: HYDROCORTISONE SUCCINATE

CAS Number
2203-97-6 (free acid); 125-04-2 (sodium salt); 83784-20-7 (hydrate)
Function
Anti-inflammatory (pharmaceutical active — corticosteroid)
Safety Rating
POOR

Regulatory Status

🇪🇺 EU Status restricted
🇺🇸 US Status restricted
US Notes OTC Drug — regulated under 21 CFR Part 348 (external analgesic). FDA classifies as a drug, not a cosmetic 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

This is a pharmaceutical active ingredient, not a cosmetic ingredient. Inclusion in a cosmetic product would reclassify it as a medicinal product under EU and US law. Systemic absorption risk, skin atrophy with prolonged use, and HPA axis suppression are documented concerns. Not approvable in a CPSR.

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Concern Level: High

Frequently Asked Questions

Is Hydroxycortisone Succinate safe in cosmetics?

This is a pharmaceutical active ingredient, not a cosmetic ingredient. Inclusion in a cosmetic product would reclassify it as a medicinal product under EU and US law. Systemic absorption risk, skin atrophy with prolonged use, and HPA axis suppression are documented concerns. Not approvable in a CPSR. The EU classifies Hydroxycortisone Succinate as "restricted". Safety rating: POOR.

Is Hydroxycortisone Succinate allowed in the EU?

Hydroxycortisone Succinate EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.

What does Hydroxycortisone Succinate do in cosmetics?

Hydroxycortisone Succinate functions as: Anti-inflammatory (pharmaceutical active — corticosteroid). It is classified as a cosmetic ingredient in our database. CAS number: 2203-97-6 (free acid); 125-04-2 (sodium salt); 83784-20-7 (hydrate).

What is the Margin of Safety for Hydroxycortisone Succinate?

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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