From Tanning Accessory to Health Necessity: History of the OTC Sunscreen Monograph in Light of the Sunscreen Revolution

Abstract

On August 27, 2007 the FDA published a Proposed Amendment to the Final Monograph for Over-the-Counter Sunscreen Drug Products. The proposed regulations marks major progress in the regulation of sunscreen products, because it includes, for the first time, comprehensive regulations addressing testing and labeling standards for both UVB and UVA regulation. Developing a monograph for sunscreen products, however, has been an arduous administrative process that has spanned over 30 years and produced significant criticism of the FDA. This article examines the regulation of sunscreen products in light of cultural and scientific developments that governed the rise and revolution of the sunscreen industry arguing that, for the most part, FDA has responded with impressive flexibility and attention to dynamic technological advancements, transformation of consumer expectations, and uncertain science.