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This article was originally published in The Tan Sheet

Executive Summary

SPF 30 IS MAXIMUM ALLOWABLE VALUE SET BY OTC SUNSCREEN TFM, which was published in a 108-page Federal Register notice on May 12. While proposing that "the upper limit for SPF values be 30," the tentative final monograph also concludes "that OTC sunscreen drug products with SPF values higher than 15 are beneficial to consumers." FDA's topical analgesic panel, which conducted its review of sunscreen ingredients in the 1970s, had proposed an upper SPF standard of 15 in its Aug. 25, 1978 panel report. "Although the agency has concluded that the available scientific data demonstrate that sunscreen drug products with SPF [sun protection factor] values above 15 are reasonable and justified," FDA said in the TFM that it found "that SPF values above 30 are not necessary because the available data clearly indicate that a sunscreen drug product with an SPF of 30 assures adequate protection for the majority of consumers even under extreme conditions." FDA stated that "scientific evidence shows a point of diminishing returns at levels above SPF 30; any benefits that might be derived from using sunscreens with SPF values higher than 30 are negligible." The agency said it "does not believe that an 'open-ended' approach to SPF values is beneficial to consumers." The TFM represents FDA's tentative adoption of the OTC topical analgesic panel's conclusions and recommendations. Written comments or requests for oral hearing on the TFM must be submitted to FDA by Nov. 8. The final monograph will become effective 12 months after the date of its publication in the Federal Register. In a May 12 press release, FDA noted that "SPF numbers above 30, which have . . . appeared on some products [since the 1978 panel report], may be used until a final regulation becomes effective, but such values are not considered necessary for most consumers." FDA declared in the TFM that "the difference in protection provided by a sunscreen drug product with an SPF 40 or 50 compared to the protection offered by a product with an SPF 30 is so small as to be nonexistent, especially when one considers the biological variability inherent in an individual's response to the protective quality of sunscreen drug products." Noting that in the southern states of the continental U.S. an individual could be exposed to "approximately 22 MEDs [minimal erythema dose] in the hottest part of the summer," FDA determined that an SPF 30 sunscreen "provides all-day protection for all skin types" as well as "an extra margin of protection that allows for the possibility that the product may be inadequately applied and accommodates weather conditions that cannot be factored into SPF testing procedures." FDA cited one comment that noted than an SPF 30 sunscreen blocks 96.7% of UV energy "whereas an SPF 40 sunscreen drug product only increases this level of protection to 97.5% and the amount of additional sunscreen ingredient 'load' in the product could realistically increase by up to 25%." The same comment pointed out that a product with an SPF of 70 would block 98.6% of UV energy. The comment suggested that products with SPF 30 or higher "represent unnecessary and ill-advised exposure to increased sunscreen ingredients at a time when dermatologists and skin cancer groups are recommending that sunscreens be applied daily to minimize the adverse effects of the sun." Responding to comments made by several researchers at a Jan. 26, 1988 FDA panel meeting that SPFs higher than 20 would unnecessarily subject consumers to an increased likelihood of skin irritation, FDA noted in the TFM "that advances in formulation technology have allowed manufacturers to develop products with relatively low levels of sunscreen active ingredients and still achieve high SPF values." FDA also cited a study submitted to the agency that found no conclusive evidence that sunscreens with SPF 15 or greater caused more skin irritation than sunscreens with SPF 15 or less. Therefore, FDA said it "does not believe that increasing the concentration of active ingredients in a sunscreen drug product will necessarily make the product more irritating." The agency concluded that after "extensively" reviewing the available data, it "does not believe that sunscreens with SPF values higher than 15 (and up to SPF 30) pose any significant safety problems." The TFM also proposes testing procedures for determining SPF values based on the use of an 8% homosalate preparation with a mean SPF value of 4.47 (standard deviation 1.279). A solar simulator used for determining the SPF value of a sunscreen should provide 290 to 400 nanometers similar to sunlight at sea level when the sun is at a zenith angle of 10%, according to the monograph. Only volunteers with fair skin should be selected. The test should be conducted on the back between the beltline and the shoulder blade and both the test and standard sunscreen preparations should be applied at 2 milligrams per square centimeter, according to the TFM. FDA recommends that each test panel consist of no more than 25 volunteers, of which at least 20 subjects must produce valid results. The MED is determined 22 to 24 hours after exposure. SPF values are equal to the ratio of erythema effective dose on protected skin (MED(PS)) to the erythema effective exposure on unprotected skin (MED(US)). In a comment to the agency on the testing procedure, the Cosmetic, Toiletry and Fragrance Association said it believes that the formulation was sufficient for the entire range of marketed SPFs. The group reported that over the past 10 years, the industry has developed a massive block of test data that substantiates its validity. FDA said it agrees "that the 8% homosalate preparation may be used to validate testing procedures with products up to and including 15." However, FDA continued, "there is currently not enough information available for the agency to determine that the use of this standard is valid for testing sunscreens with SPF values above 15." FDA cited concerns expressed in several comments "about using a standard preparation that may have a relatively low SPF value of 4 to validate a sunscreen testing procedure that is supposed to determine a wide range of SPF values." From data submitted to the agency, FDA determined that although the 8% homosalate solution is suitable in determining SPF values up to 15, the agency "believes that one or more additional standard preparations with SPF values higher than four may be desirable for testing sunscreens with higher SPF values." However, FDA stated that "at this time, the agency does not have enough data or information to reach a conclusion regarding the use of other suitable standards or their formulations."

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