ABSTRACT
Differentiating Drug, Cosmetic, and Drug-Cosmetic Products 86
Regulatory Mechanisms for Marketing Sunscreen Drug Products 87
New Drug Application 87
OTC Drug Monograph System 89
Description of the OTC Drug Monograph System 89
Advisory Panel Review 90
Tentative Final Monograph 91
Final Monograph 91
Description of an OTC Drug Monograph 91
Amending an OTC Drug Monograph 93
Citizen Petition 93
Time and Extent Application 93
This chapter describes how the Food and Drug Administration (FDA) regulates
products containing sunscreen active ingredients. FDA regulates these products
based on the Code of Federal Regulations (CFR), which derives from the
Federal Food, Drug, and Cosmetic Act (the Act), legislation enacted by
Congress. Discussion will begin with differentiation of drug and cosmetic pro-
ducts according to the CFR. Then, the remainder of the chapter will focus on
sunscreen drug products. The two mechanisms under which sunscreen drug
products can be regulated will be compared and contrasted. Because the most
common regulatory mechanism for marketing sunscreen drug products is the
over-the-counter (OTC) drug monograph system, the OTC sunscreen drug mono-
graph will be used to explain this system. Finally, two mechanisms by which an
OTC drug monograph can be amended will be described.
