Excellent Active Ingredient

Colloidal Oatmeal

INCI: AVENA SATIVA KERNEL FLOUR

CAS Number
131707-24-9
Function
Skin Protectant, Anti-inflammatory, Antipruritic
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes FDA Category I OTC Skin Protectant active ingredient under Final Monograph 21 CFR Part 347 (June 2003) and OTC Monograph M016 (updated Sept 2021). Approved concentration: minimum 0.007%. Approved indications: temporarily protects and helps relieve minor skin irritation and itching due to rashes, eczema, poison ivy/oak/sumac, and insect bites. Products marketed as OTC skin protectants are considered drugs under US law.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
negligible
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Colloidal Oatmeal (AVENA SATIVA KERNEL FLOUR) is permitted in the EU with no restrictions and is not listed in any annex of EC 1223/2009. In the US, it is an FDA OTC Skin Protectant Category I active ingredient approved at minimum 0.007% concentration under 21 CFR 347 and OTC Monograph M016. CIR Expert Panel (2019) concluded it is safe when formulated to be nonsensitizing, with negligible systemic exposure from cosmetic use.

⚠️
Concern Level: Low

Regulatory Flags

otc-drug-dual-status oat-allergy-risk atopic-dermatitis-caution fda-category-i-skin-protectant gras-food-grade

Frequently Asked Questions

Is Colloidal Oatmeal safe in cosmetics?

Colloidal Oatmeal (AVENA SATIVA KERNEL FLOUR) is permitted in the EU with no restrictions and is not listed in any annex of EC 1223/2009. In the US, it is an FDA OTC Skin Protectant Category I active ingredient approved at minimum 0.007% concentration under 21 CFR 347 and OTC Monograph M016. CIR Expert Panel (2019) concluded it is safe when formulated to be nonsensitizing, with negligible systemic exposure from cosmetic use. The EU classifies Colloidal Oatmeal as "permitted". Safety rating: EXCELLENT.

Is Colloidal Oatmeal allowed in the EU?

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

What does Colloidal Oatmeal do in cosmetics?

Colloidal Oatmeal functions as: Skin Protectant, Anti-inflammatory, Antipruritic. It is classified as a Active Ingredient in our database. CAS number: 131707-24-9.

What is the Margin of Safety for Colloidal Oatmeal?

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.

Compliance Tools

Check Colloidal Oatmeal compliance across multiple jurisdictions:

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Ingredient Decoder
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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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