Colloidal Oatmeal
What Is It?
Avena Sativa (Oat) KernelThe inner, softer part of the seed or nut contained inside the seed coat. MealA coarsely ground grain. and Colloidal Oatmeal are both ground kernels of oats. These ingredients are used in skin care, bath products and soaps and detergents.
Why Is It Used?
As a skin protectantAn ingredient that temporarily protects injured or exposed skin from harmful or annoying stimuli, and that may provide relief to such skin. In the United States, skin protectants are regulated as Over-The-Counter (OTC) drug ingredients., Colloidal Oatmeal temporarily protects injured or exposed skin from harmful or annoying stimuli, and may therefore provide relief to the skin. Avena Sativa (Oat) Kernel Meal and Colloidal Oatmeal also function as abrasives, absorbents and bulking agents.
Scientific Facts
Colloidal Oatmeal is finely ground oatmeal. It is often used to relieve minor skin irritation and itching due to poison ivy or insect bites. It can also be used as a soak, compress or wet dressing. When oatmeal is used in cosmetic and personal care products (rather than OTC skin protectant drug products), it may be called Avena Sativa (Oat) Kernel Meal.
Safety Information
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 ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (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/CFRSearch.cfm?fr…
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 Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..
Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…
More Scientific Information
Avena Sativa (Oat) Kernel Meal and Colloidal Oatmeal belong to a large and diverse class of materials that are not defined chemically. Specific ingredients derived from biological sources are classified on the basis of their chemistry and the majority of the materials in this class are mixtures derived from plants. In cosmetics and personal care products, Avena Sativa (Oat) Kernel Meal and Colloidal Oatmeal function as abrasives, absorbents and bulking agents. Colloidal Oatmeal also functions as a skin protectant.
Resources
Find out more about the regulation of over-the-counter drugs by the Food and Drug Administration
OTC Drug Home Page: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSa…
Information about OTC Drug monographs: https://www.fda.gov/drugs/over-counter-otc-drug-monograph-process
Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/