Moderate Active Ingredient Sensitization Data

Selenium Sulfide

INCI: SELENIUM SULFIDE

CAS Number
7488-56-4
Function
Anti-dandruff active; antifungal
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status restricted
US Notes FDA OTC Monograph M032: 1% rinse-off for dandruff control; 2.5% is Rx-only drug

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
high
Sensitization
moderate

Calculate MoS for your specific formulation with the MoS Calculator.

Sensitization Profile

Contact sensitization data for Selenium Sulfide based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.2%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis

Source: IVDK; SCCS

Expert Verdict

Selenium sulfide at 1% is regulated as an OTC drug under FDA Monograph M032 in the US, while concentrations of 2.5% are prescription-only. In the EU, it is prohibited as a cosmetic ingredient and regulated as a medicinal product, making it not viable for EU cosmetic formulations.

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Concern Level: Moderate

Regulatory Flags

eu-not-listed otc-drug-us medicinal-eu drug-cosmetic-boundary eu_cosing_listed

Frequently Asked Questions

Is Selenium Sulfide safe in cosmetics?

Selenium sulfide at 1% is regulated as an OTC drug under FDA Monograph M032 in the US, while concentrations of 2.5% are prescription-only. In the EU, it is prohibited as a cosmetic ingredient and regulated as a medicinal product, making it not viable for EU cosmetic formulations. The EU classifies Selenium Sulfide as "prohibited". Safety rating: MODERATE.

Is Selenium Sulfide allowed in the EU?

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

What does Selenium Sulfide do in cosmetics?

Selenium Sulfide functions as: Anti-dandruff active; antifungal. It is classified as a Active Ingredient in our database. CAS number: 7488-56-4.

What is the Margin of Safety for Selenium Sulfide?

adequate 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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