When you think of a cosmetic, do you think of your shampoo? How about your deodorant? Now, when you think of an over-the-counter drug, do you think of your fluoride toothpaste? How about your moisturizer with SPF? You may be surprised by what is considered a cosmetic and what is considered an over the counter drug by the FDA.

According to the FDA, a cosmetic is defined 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”. It defines drugs as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease… and articles (other than food) intended to affect the structure or any function of the body of man or other animals” (FDA).

Some commonly known cosmetics are eyeshadows, lipsticks, foundations, etc. Some cosmetics you may not have known were cosmetics include tattoo ink, henna, toothpastes (that do not include fluoride), and skin moisturizers (without SPF).

Some over-the-counter drugs that everyone knows about include aspirin, cold medicines, and cough drops. You might be surprised to learn that hand sanitizer, acne cleansers, and petroleum jelly are considered drugs by the FDA as well.

It is important to remember that this is according to the US definitions of cosmetics and over-the-counter drugs, and there are different regulations in other parts of the world. For example, in the EU sunscreen is a cosmetic, rather than an over-the-counter drug as defined by the FDA.

We are able to assist you in determining whether your product qualifies as a cosmetic or over-the-counter drug in the US and abroad, and then receiving the proper certifications for them as well! Check out our services page for a comprehensive list of all our services.

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