Expand Sunscreens are regulated by FDA as over-the-counter (OTC) drugs. As such, they must be shown to be both safe and effective and must comply with all other requirements listed in FDA's OTC sunscreen monograph. Individual sunscreen active ingredients are reviewed by FDA and only those that are identified for use in the monograph may be used in sunscreen products marketed in the U.S. Updates and changes to the monograph are issued via a public rule-making process. On February 26, 2019, FDA published the updated proposed rule for sunscreens, known as the Tentative Final Monograph (TFM). Because of deadlines imposed by the Sunscreen Innovation Act, FDA has stated that it must finalize the TFM by November 26, 2019.