Colloidal Oatmeal
Colloidal oatmeal is an FDA-approved OTC skin protectant active ingredient, listed in the OTC monograph (21 CFR Part 347 / Monograph M016). Permitted concentrations: 0.007% minimum (or 0.003% with mineral oil).
What it is
Colloidal oatmeal — finely ground whole oat (Avena sativa) milled to a powder fine enough to form a stable colloidal dispersion in water.
Skin protectant active ingredient (cosmetic/OTC drug), also used as a thickener; in food it is uncommon but starch-derivative use is possible.
Why it's flagged
- rare oat allergy
- potential gluten cross-contamination concerns for celiac
What regulators actually say
"Colloidal oatmeal 0.007 percent minimum; 0.003 percent minimum in combination with mineral oil — listed as a skin protectant active ingredient."
"FDA OTC Monograph M016 — Skin Protectant Drug Products for OTC Human Use lists colloidal oatmeal as an approved active ingredient."
Regulatory status
United States — FDA
OTC skin protectant active under 21 CFR 347.10 (now M016)
European Union — EFSA
Cosmetic/topical use under EU 1223/2009; standard food use for whole oat
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