Q: What are the differences between an over-the-counter(OTC) drug product and a cosmetic?


 A: 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. Among the products 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.

 

Source: Excerpted from Office of Cosmetics and Colors Fact Sheet, July 8, 2002: Is It a Cosmetic, a Drug, or Both? (or Is It Soap?)

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