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FDA proposes changes to US sunscreen rules﻿

The US Food and Drug Administration is seeking data to determine whether certain ingredients found in sunscreens sold in the US are safe and effective. The agency is also looking to expand the range of ultraviolet light that sunscreens block. Under a rule proposed by the FDA on Feb. 21, manufacturers would need to provide the FDA with safety data if their products contain any of 12 sunscreen chemicals currently in use. The FDA needs such data so it can finalize what is called an over-the-counter (OTC) monograph for sunscreens by Nov. 29, the deadline set by the 2014 Sunscreen Innovation Act. The monograph is a set of standards under which certain OTC drugs can be marketed without new drug applications because they are generally recognized as safe and effective (GRASE). The agency is proposing to categorize zinc oxide and titanium dioxide GRASE without additional data. The FDA is also