Schering-Plough seeks FDA expedited sun tanning products warning requirement.
This article was originally published in The Rose Sheet
Executive Summary
SUN TANNING PRODUCT EXPEDITED LABEL WARNING REQUESTED BY SCHERING-PLOUGH in a July 1 citizen petition submitted to FDA. Referring to a warning requirement for "cosmetic sun tanning products" without active sunscreen ingredients proposed by the agency in its tentative final monograph for sunscreen drug products (proposed in 1993), the Coppertone manufacturer requests that FDA "immediately issue [the] regulation prescribing a warning" for such products.