October 2022 • Vol. 28 • Issue 8
Colloidal Oatmeal – An OTC Monograph Skin Protectant Ingredient with Exceptional Properties
T
…Paul Thau
he use of oats for skin care dates to ancient Egypt. Whole or rolled oats were used in soothing baths. Oats used in this way did not disperse well in baths and were messy. In 1945, technological advances permitted the manufacture of colloidal oatmeal which is prepared from de-hulled oats ground to a fine powder. The first ready-to-use colloidal oatmeal bath treatment was presented at the Mayo Clinic in 1945. Colloidal oatmeal retains the moisturizing effects of the whole oat grain, but disperses more easily in bath water and can also be added to creams and lotions for use in topical products. Colloidal oatmeal is obtained from grinding the whole seed. All components are preserved: approximately 60% polysaccharides, 10-18% proteins, 5% lipids (e.g., phospholipids, sterols, etc.), enzymes, vitamins, flavonoids, and phenolic acids (e.g., avenanthramides). Oatmeal can help restore normal pH of skin in conditions where the pH is high. In this setting, it acts as a buffering agent, thereby aiding in the maintenance of a healthy skin barrier. The moisturizing properties of colloidal oatmeal are provided by a hydrophilic film that forms at the skin surface. It consists of humectant and water-binding constituents as well as lipids. Starches are also important constituents of colloidal oatmeal. They are very hydrophilic and can absorb large quantities of water. Proteins in colloidal oatmeal further contribute to its affinity for water. The unique lipid composition of colloidal oatmeal contributes to the formation of a film at the skin’s surface. Oat triglycerides and phospholipids, as well as oleic, linoleic, and linolenic acids are important lipids found in oats. Avenanthramides are the main polyphenolic antioxidants in oat grains, demonstrating greater antioxidant activity (ten- to thirty-fold greater) than that of the other oat phenolic compounds such as vanillin or caffeic acid, and five-fold greater than that of oat flavonoids. Colloidal oatmeal provides gentle cleansing without loss of the skin’s moisture content. It thus helps prevent skin dryness and the clinical signs associated with skin dryness. Colloidal oatmeal is included in the Over-the-Counter (OTC) Monograph M016: Skin Protectant Drug Products for Over-the-Counter Human Use published by the Food and Drug Administration (FDA). Colloidal Oatmeal Raw Material has been classed by the FDA and Health Canada as a ‘skin protectant’ and ‘natural health product (NHP)’, respectively. Thus, should a manufacturer wish to do so, colloidal oatmeal can be incorporated as an active ingredient in OTC drug products or natural health products designed and marketed to offer temporary protection and relief to those with skin irritation or injury. The formulation, label information, and marketing claims should adhere to the specifications on the FDA OTC Monograph. Colloidal oatmeal meets the USP (United States Pharmacopeia) standards for purity, composition, and particle size. It consists of superfine oat flour with a (continued on Page 9)
S U S TA I N A B I L I T Y
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O C T O B E R
...see pages 6-9 for more information.
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