Active ingredient is an official term used by the FDA for materials that are classified as either over-the-counter (OTC) or prescription drugs. For products sold in the United States, active ingredients must be called out separately on the primary package with specific labeling requirements known as Drug Facts.
The Federal Food, Drug and Cosmetic Act defines cosmetics by their intended use as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body … for cleansing, beautifying, promoting attractiveness or altering the appearance.” A cosmetic ingredient is intended to affect the appearance or have other aesthetic benefits without altering the function or structure of the body. Materials classified as cosmetic must be listed in the ingredient declaration. Ingredients that are in a formulation at greater than 1 percent must be listed in order of concentration with those at the highest concentrations listed first.