Sunscreen Drug Products for Over-the-Counter Human Use; Final Monograph; Partial Stay; Final Rule

The Food and Drug Administration (FDA) is staying the final monograph for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of May 21, 1999 (64 FR 27666). The final monograph established conditions under which OTC sunscreen drug products are generally recognized as safe and effective and not misbranded. This stay of effective date applies to all OTC sunscreen drug products that would be regulated under part 352 (21 CFR part 352). This action does not stay the effective date for products that would be regulated under parts 310 and 700 (21 CFR parts 310 and 700). This action is being taken because the agency will be amending part 352 to address formulation, labeling, and testing requirements for both ultraviolet A (UVA) radiation protection and ultraviolet B (UVB) radiation protection. This action is part of FDA's ongoing review of OTC drug products.