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PROPYL METHOXYCINNAMATE's USE AS SUNSCREEN IN S.C. JOHNSON's SUNSTICK

Executive Summary

PROPYL METHOXYCINNAMATE's USE AS SUNSCREEN IN S.C. JOHNSON's SUNSTICK was cited by Estee Lauder in an Oct. 8 letter to FDA as the basis for continued marketing of Estee Lauder products containing the ingredient. The firm's outside counsel, William Pendergast (D.C. firm Arent, Fox, Kintner, Plotkin & Kahn), stated that "it is Lauder's understanding that propyl methoxycinnamate was used as a drug ingredient in an OTC sunscreen preparation prior to 1975 and therefore it may be properly used in an OTC sunscreen preparation today." FDA told Estee Lauder in a Sept. 5 regulatory letter that all its products except "Golden Sun Pre-Tan Accelerator" contain the sunscreen ingredients butyl methoxydibenzoylmethane, and/or propyl methoxycinnamate, which the agency said "have not been marketed in the U.S. prior to Dec. 4, 1975 as sunscreen agents, nor to our knowledge is there any substantial scientific evidence that they are recognized as safe and effective for their intended uses" ("The Pink Sheet" Sept. 16, T&G-12). Pendergast said Estee Lauder learned from the supplier, Firmenich, that SunStick contains an active compound called "Solprotex," which includes propyl methoxycinnamate, digalloyl trioleate, homosalate and glyceryl dioleate. In a Sept. 24 letter to Estee Lauder, included in Lauder's reponse to FDA, Firmenich Technical Director Robert Raymond stated that Solprotex I is "the subject of an NDA which probably dates back to the 1960s." He said Firmenich "submitted to the FDA in 1963 its safety, efficacy and manufacturing data for Solprotex I to support the NDA for SunStick." FDA may not have been aware of the use of propyl methoxycinnamate in SunStick because the label lists digalloyl trioleate as the active ingredient, when the product actually contains Solprotex I, Raymond suggested. "This confusion probably dates back to the 1960s when Solprotex I was identified as a "brand of Digalloyl Trioleate' in the submission to FDA" for the NDA, he explained. With regard to the ingredient butyl methoydibenzoylmethane, Pendergast asserted that Estee Lauder "has decided there is no basis for removing this ingredient from its products." He said it is not listed as an active OTC drug ingredient in any of the four Lauder sunscreen products containing it. Clarins agreed to reformulate its sunscreen products to delete the ingredient last May. FDA had also told the firm that SPF (Sunscreen Protection Factor) designations higher than 15 could not be used. Estee Lauder contended that such designations can be supported by valid scientific evidence. The firm argued that it is appropriate to use SPF factors above 15 since the OTC panel's report is only a proposal and because SPF-23 claims are truthful. Last spring FDA acknowledged that the SPF standards recommended by the OTC panel may need revision and sought comments from the Proprietary Assn. on technical developments in the field and the possible modifcation of the SPF numbering system ("The Pink Sheet" April 29, T&G-2).
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PS009190

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