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Home :: Professional / Government Regulation / FDA Requirements and Programs / Over the Counter Drugs Versus Cosmetics

U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics Fact Sheet
February 3, 1995

OTC vs. COSMETIC

The Food, Drug & Cosmetic Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. Included in this definition are skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.

Products that intend to treat or prevent disease, or otherwise affect the structure or functions of the human body, are considered drugs. Over-the-counter drugs are drugs that can be purchased without a doctor's prescription. Examples of products that are over-the-counter drugs are fluoride toothpastes, hormone creams, sunscreen preparations, antiperspirants, and antidandruff shampoos.


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