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This article was originally published in The Tan Sheet

Executive Summary

P&G SUPPORTS FDA PROPOSAL TO CAP SUNSCREEN SPFs AT 30 in order to avoid consumer confusion, the company said in Oct. 29 comments submitted on the OTC sunscreen tentative final monograph published in the May 12 Federal Register ("The Tan Sheet" May 17, pp. 10- 19). Procter & Gamble said it believes that FDA's proposal to limit sun protection factor claims at 30 "is appropriate to end the "horsepower race' which can mislead consumers with regard to incremental benefit and lead to overuse of sunscreen actives." The higher SPFS, P&G contended, "wrongly focus purchase decision-making on a single attribute of a sunscreen product." P&G suggested that "real consumer benefit is achieved through the appropriate balance of sunscreen product efficacy attributes including substantivity, UVA protection, irritation and cost." With that in mind, P&G urged FDA to "remove the incentive to create single-focus products." P&G also asserted that encouraging a focus on higher SPFs creates unnecessarily high costs for consumers. The "consumer perception that an SPF 45 product automatically delivers protection superior to SPF 30, simply because it is a higher number, drives purchase decisions toward high-priced, higher SPF products," P&G stated. The company urged FDA to "consider that a minimal incremental benefit exists above SPF 30." FDA requested scientific data to support SPF values over 30 for sunscreen products in July I letters to the Nonprescription Drug Manufacturers Association and the Cosmetic, Toiletry and Fragrance Association ("The Tan Sheet" July 19, p. 10). In that letter, FDA Monograph Review Staff Director William Gilbertson noted that the agency has "already received several comments objecting" to an SPF upper limit. Schering-Plough, manufacturer of the Coppertone line of sunscreens, issued a press release during the summer objecting to FDA's proposed SPF cap ("The Tan Sheet" July 19, p. 10). Schering has not yet submitted comments on SPFs to the agency. Companies were given an extension of 90 days beyond the Nov. 8 deadline to comment on non-UVA issues. While agreeing with FDA's SPF upper limit, P&G took issue with other parts of the sunscreen proposal. P&G disagreed with FDA's recommendation to include minimum doses for sunscreens used in combination with one another. Instead, the company argued that the effectiveness of a sunscreen "should be evaluated solely on the performance of the finished product." P&G suggested that the proposal would act as a "disincentive" to sunscreen manufacturers to develop effective sunscreen formulations. In response to FDA's argument that the proposal would prevent manufacturers from using the addition of extremely low levels of sunscreen as a marketing tool, P&G suggested that the agency has "far better remedies available such as regulatory letters, seizure of product and litigation for misleading or deceptively marketed OTC product." The company maintained that the "choice of sunscreens . . . is of little interest to consumers and is irrelevant since the efficacy of the product is measured by its SPF, not the specific sunscreens present." P&G also stressed the importance of evaluating the finished sunscreen product rather than individual ingredients since the "contribution of an individual sunscreen in a combination product will vary greatly with the formulation." Therefore, P&G requested that FDA withdraw its proposal calling for sunscreen manufacturers to develop methods that demonstrate the contribution of each ingredient in a combination sunscreen product. Procter & Gamble requested that FDA add Parsol 1789 to the list of Category I (safe and effective) active ingredients. P&G maintained that the material is safe and effective and "uniquely affords long wavelength (UVA 1) protection". The company contended that "consumers will continue to be deprived of the opportunity to protect themselves from this damaging radiation" if FDA delays in giving Parsol 1789 monograph status. Regarding non-beach products, P&G suggested that FDA delete the proposed usage directions for products such as lipsticks and make-up preparations. P&G contended that it is "unlikely that consumers would modify their habits of lipstick application and usage simply because it contains a sunscreen." The company also recommended that FDA's proposed warning statement, aimed at ensuring that products with SPFs over 4 be used on young children and infants, be required only on preparations providing an SPF of four or less. P&G also objected to FDA's proposal to require dual SPF values for water-resistant products. The company suggested that if water- resistant claims are made, the SPF value on the label should be the value after water-resistance testing. If FDA decides that a second SPF value be included in labeling, P&G recommended that it be "reserved" for UVA protection.

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