FDA Extends Comment Period on Proposed Requirements for OTC Sunscreen

The Food and Drug Administration is extending the comment period on its proposed rule to create a “monograph” for over-the-counter sunscreen that would set conditions for selling sunscreen in the U.S. without prior approval from the agency (see 1902210019). 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. FDA currently operates under a policy of enforcement discretion for unapproved sunscreens that contain ingredients that were set to be recognized as safe in an earlier rulemaking effort on sunscreens (see 1805220043). Comments are now due June 27. FDA also issued a correction to its Feb. 26 proposed rule.