Good Cosmetic Ingredient

Ozokerite

INCI: OZOKERITE

CAS Number
12198-93-5
Function
Film-forming agent, emollient
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes Permitted in cosmetics without restriction. CIR Expert Panel concluded safe for use at present practices of concentration and use (1984, reaffirmed 2003). Listed in 21 CFR 175.105 as indirect food additive for adhesives. No FDA concentration limits apply.

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
negligible
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Ozokerite is a mineral hydrocarbon wax permitted without restriction in EU and US cosmetics; dermal absorption studies demonstrate no systemic availability and human sensitization studies confirm no dermal sensitization potential, though oral rodent carcinogenicity studies are considered of uncertain relevance to cosmetic use when highly refined.

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Concern Level: Low

Regulatory Flags

eu-unrestricted cir-approved no-sccs-opinion

Frequently Asked Questions

Is Ozokerite safe in cosmetics?

Ozokerite is a mineral hydrocarbon wax permitted without restriction in EU and US cosmetics; dermal absorption studies demonstrate no systemic availability and human sensitization studies confirm no dermal sensitization potential, though oral rodent carcinogenicity studies are considered of uncertain relevance to cosmetic use when highly refined. The EU classifies Ozokerite as "permitted". Safety rating: GOOD.

Is Ozokerite allowed in the EU?

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

What does Ozokerite do in cosmetics?

Ozokerite functions as: Film-forming agent, emollient. It is classified as a Cosmetic Ingredient in our database. CAS number: 12198-93-5.

What is the Margin of Safety for Ozokerite?

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.

Compliance Tools

Check Ozokerite compliance across multiple jurisdictions:

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Ingredient Decoder
Paste a full ingredient list for instant analysis
 🌸
82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
Check compliance across 55 jurisdictions
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
Compare limits across jurisdictions

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