Parsol 1789
This article was originally published in The Tan Sheet
Executive Summary
FDA has "tentatively concluded that [Parsol 1789] cannot be included in the [OTC sunscreen drug products] monograph at this time," Jeanne Rippere of FDA's Office of OTC Drug Evaluation told a Nov. 16 FDA Compliance Seminar in Washington, D.C. Although Rippere noted that the agency is still evaluating additional data, including data submitted by Givaudan-Roure ("The Tan Sheet" Sept. 26, p. 16), FDA "felt [it] needed to know more about Parsol and its interaction with other sunscreens with which it might be combined under the OTC monograph system." Explaining FDA's cautious approach to Parsol 1789, Rippere also cited "reports of increased incidence of sensitization from dibenzoylmethanes in Europe," "adverse drug experiences" and "recent problems" associated with Allergan Herbert's Photoplex, which the company withdrew from the U.S. last year due to marketing considerations