FDA Issues Proposed Rule to Set Long-Awaited Requirements for OTC Sunscreen

The Food and Drug Administration is issuing a proposed rule to finally put into effect a “monograph” for over-the-counter sunscreen that would set conditions for selling sunscreen in the U.S. without prior approval from the agency. The renewed effort follows a monograph for sunscreen issued in 1999 that never went into effect, but that forms the basis for FDA’s current policy of enforcement discretion for unapproved sunscreens that contain ingredients that were set to be recognized as safe in the rule (see 1805220043). The proposed rule would formally allow sale in the U.S. of sunscreens, without a new drug application, that contain certain ingredients recognized by FDA to be safe. Comments are due May 27.