Abstract

There has never been an OTC Monograph in effect for sunscreen products in the United States. The history of sunscreen regulation in the United States is complex and lengthy. In 2011, the U.S. Food and Drug Administration (FDA) published a final regulation on testing and labeling of sunscreens; this is not a Monograph. Many aspects of sunscreen regulation remain unresolved, such as active ingredients, dosage forms, indications (claims), instructions for use for sprays, maximum SPF and other issues. This article provides a 35-year review of the Sunscreen Monograph and a look at FDA priorities for the next five years or more. In addition to recounting the specific steps in the evolution of the Monograph, this article will discuss the other factors that have influenced the Monograph in the past and are likely to affect its scope, content and status in the future.

 There has never been an OTC Monograph in effect for sunscreen products in the United States. To many readers, this will come as a surprise, even if you know what a monograph is. However, the history of sunscreen regulation in the United States is long and complicated. After nearly 40 years of rulemaking, in 2011, the U.S. Food and Drug Administration (FDA) published a final rule on sunscreens. Many people understand this rule to be a “monograph,” but it is not. It is a regulation on labeling and testing. Many other aspects of sunscreen regulation remain unresolved. This article intends to provide a retrospective on the development of U.S. sunscreen regulations and a prospective view for the next five to ten years. In addition to recounting the specific steps in the evolution of the Monograph, this article will discuss the other factors that have influenced the Monograph in the past and are likely to affect its character in the future.