Colloidal Oatmeal

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Avena Sativa (Oat) Kernel Meal and Colloidal Oatmeal are both ground kernels of oats. These ingredients are used in skin care, bath products and soaps and detergents.

The Food and Drug Administration (FDA) reviewed the safety and efficacy of Colloidal Oatmeal and approved its use as an active ingredient in Over-the-Counter (OTC) skin protectant drug products at a minimum concentration of 0.007%, or 0.003% when used in combination with mineral oil. When used as a skin protectant in an OTC skin protectant drug product, this ingredient must be called Colloidal Oatmeal.

The Cosmetic Ingredient Review (CIR) has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.Link to FDA Code of Federal Regulations for Colloidal Oatmeal
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

Avena Sativa (Oat) Kernel Meal and Colloidal Oatmeal may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union.
Link to the EU Cosmetics Directive: http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...

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