OTC vs. Non-OTC

First, to explain: Cosmetic vs. Drug as defined by the FDA

The FDA addresses the use of drugs and cosmetics under the Federal Food, Drug and Cosmetic Act, enacted in 1938 and amended numerous times to remain current. It draws distinction between cosmetics and drugs.

A cosmetic is defined as any product that is “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 drug is defined as any product that is “intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease” or any product “intended to affect the structure or any function of the body of humans or other animals.” [FD&C Act, 201 (g)(1)].

Cosmetic & Drug
Some personal care products meet the definitions of both a cosmetic and a drug because they have two intended uses. Among these are anti-dandruff shampoos; deodorant/antiperspirants; skin protectants such as lip balms and diaper ointments, and moisturizers and makeup with sun-protection claims.

OTC Cosmetic or Skincare Product
A Formula that contains active ingredients and in a concentration that may affect the physiology of the human skin is classified as a drug. These OTC (over-the-counter) products must comply with the requirements for both cosmetics and drugs. The product must be made with pharmaceutical-grade ingredients and manufactured in an FDA inspected, cGMP-compliant facility. OTC cosmetic and skincare products are readily available to consumers without a prescription from a healthcare professional.