ESTEE LAUDER SUN CARE PRODUCT REFORMULATION will be made as directed by FDA, the company told the agency at a June 19 meeting. The new formulations will eliminate sunscreen ingredients butyl methoxydibenzoylmethane and propyl methoxycinnamate. Estee Lauder was responding to a March 28 letter in which the agency threatened to invoke regulatory sanctions against the company unless the changes were made ("The Pink Sheet" April 7, T&G-10). Lauder had earlier informed FDA that it would not remove the two active sunscreen ingredients at issue. In its initial reg letter to Lauder last September, FDA said that the two ingredients are unapproved new drugs requiring premarket approval. Lauder will reformulate all new batches of Estee Lauder Sun and Prescriptives products, but FDA is permitting the company to sell the remaining stock in its present form. In addition to the reformulation agreement, melanin acceleration claims made for six Lauder Sun products, including Pre-Tan Accelerator and Golden Sun Tanning Milk SPF 4, will be further modified in line with FDA's request. Besides Lauder, other companies making melanin production claims or using the disputed sunscreen ingredients could be subject to future FDA action, the agency said. Clarins agreed to drop butyl methoxydibenzoylmethane from its sunscreen products last year following a similar FDA reg letter. Lauder had already agreed to some modifications related to claims for the prevention of sunburn, but these did not go far enough in FDA's view, an agency official said. The melanin references which appear on the products' packaging and promotional material include: "Contains an exclusive melanin stimulator . . . to speed up the skin's own melanin production" and "Biotan, an exclusive complex that works to accelerate the skin's natural production of melanin." The Lauder Sun products containing butyl methoxydibenzoylmethane are: Golden Sun Tanning Milk SPF 4; Golden Sun Tanning Lotion SPF 8; Ultra Screening Creme SPF 15; Apres Tan Maintainer for Body; Apres Sun Maintainer for Face and Prescriptives Hand Smoother. Propyl methoxycinnamate is in the Prescriptives Advanced Sun Protection SPF 6 and Advanced Sun Protection SPF 10 products, Lauder Sun Golden Sunning Lotion SPF 8 and Golden Sun Tanning Milk SPF 4.
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