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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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