Colloidal Oatmeal

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.

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.