With FDA’s final sunscreen monograph reportedly around the corner, a greater percentage of sunscreens garnered the Environmental Working Group’s approval this year than in past market surveys, but the group still has concerns about sunscreen regulation and ingredient safety.

With FDA’s final sunscreen monograph reportedly around the corner, a greater percentage of sunscreens garnered the Environmental Working Group’s approval this year than in past market surveys, but the group still has concerns about sunscreen regulation and ingredient safety.

According to Department of Health and Human Services' Dec. 7 semi-annual agenda, FDA aims to publish a final monograph for OTC sunscreen products in May. The agency has missed its target before, shooting for September in its summer 2009 agenda (1"The Rose Sheet" June 1, 2009). The final version of the monograph - which would address requirements for UVA protection - initially emerged in 1999 but has been consistently delayed. "FDA believes it is important to public health that we issue a final rule for OTC sunscreens as soon as possible," an FDA spokeswoman wrote in a March 17 e-mail to "The Rose Sheet." The agency is likely to take fire if another summer passes without formal protection standards for sunscreen manufacturers (2"The Rose Sheet" Nov. 24, 2008, In Brief)