P&G Avobenzone Combo Data Demonstrate Broad Spectrum Protection - FDA
This article was originally published in The Rose Sheet
Executive Summary
The combinations of avobenzone and either zinc oxide or phenylbenzimidazole sulfonic acid (PBSA) are safe and effective for use in sunscreens "when used in the concentrations established for each ingredient" in the sunscreen final monograph, FDA tells Procter & Gamble in a Nov. 2 letter.
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The combinations of avobenzone and either zinc oxide or phenylbenzimidazole sulfonic acid (PBSA) are safe and effective for use in sunscreens "when used in the concentrations established for each ingredient" in the sunscreen final monograph, FDA tells Procter & Gamble in a Nov. 2 letter. The agency has "determined that the data are sufficient to demonstrate 'broad spectrum' and/or UVA radiation protection potential of avobenzone with [PBSA] and avobenzone with zinc oxide," the letter says. PBSA "does not provide significant UVA radiation protection (due to it being primarily a UVB radiation absorbing sunscreen ingredient)," the agency states. However, FDA believes PBSA, "when combined with avobenzone, can contribute to 'broad spectrum' protection." In addition, "due to the ability of zinc oxide to provide 'broad spectrum' protection, we also believe that zinc oxide combined with avobenzone can contribute to 'broad spectrum' protection and provide added protection from UVA radiation," the letter states. However, the marketing of sunscreens with either of the combinations "will not be permitted" until FDA completes the necessary notice and comment procedures for a monograph change. Following publication of a proposed amendment to the sunscreen final monograph and subsequent comment period, the agency will evaluate the comments received and publish in the Federal Register a final determination on the sale of sunscreen products containing the avobenzone combinations, the agency explains. The letter comes in response to P&G's recent submission of in vivo data demonstrating "the UVA radiation protection potential" of avobenzone with PBSA or zinc oxide. In its May 11 submission, P&G reported the results of a double-blind study in 38 subjects using the UVA protection factor (PFA) methodology (1 (Also see "P&G on UVA" - HBW Insight, 14 Jun, 1999.)). The trial compared the minimal responsive dose (MRD) of UVA light after 16-24 hours of exposure. The exposure time is defined as "the lowest dose of UVA radiation that causes a minimally perceptible response," for unprotected skin versus the agent alone and the combinations of compounds. The PFA is the ratio of the MRD for protected skin to the MRD for unprotected skin. Avobenzone, PBSA and zinc oxide had mean PFAs of 3.1, 1.4 and 2.3, respectively. Avobenzone combined with PBSA raised the average PFA to 3.6, while the combination of avobenzone and zinc oxide had a mean PFA of 5.6. The study used 3% avobenzone alone or in conjunction with 1.5% PBSA and 4% zinc oxide - amounts that fall within the levels established in the sunscreen monograph. FDA allows the use of 16 active sunscreen ingredients in the final monograph, published in the May 21 Federal Register (2 (Also see ""SPF 30 Plus" Term Required For High-Protection Sunscreens - FDA Final Reg" - HBW Insight, 24 May, 1999.)). Avobenzone and zinc were added to the tentative monograph in 1996 and 1998, respectively. FDA's positive response is the latest in a series of communications resulting from Procter & Gamble's June 24, 1997 citizen petition requesting FDA amend the sunscreen tentative final monograph to include the use of avobenzone with PBSA and zinc oxide. FDA determined additional efficacy data are needed before the agency could approve the combinations (3 (Also see "Avobenzone/Zinc/Phenylbenzimidazole Sunscreen Efficacy Data Needed - FDA" - HBW Insight, 5 Oct, 1998.)). Roche Vitamins noted its endorsement of the avobenzone combinations in Nov. 12, 1998 comments to FDA, stating P&G "has adequately and appropriately addressed FDA's follow-up questions." Roche manufactures and markets Parsol 1789 (avobenzone) for use in sunscreen products. P&G provided additional data in a Feb. 26 filing, which FDA found to be "insufficient" (4 (Also see "P&G Avobenzone Combos UVA Protection Data "Insufficient" - FDA" - HBW Insight, 26 Apr, 1999.)). P&G filed the information following an OTC "feedback" meeting Jan. 27. Procter & Gamble does not market a traditional sunscreen product in the U.S. However, the firm sells Oil of Olay Complete UV Protective Moisturizer with micronized zinc oxide. Launched in January, the product replaced Daily UV Protectant, an SPF 15 moisturizer with octyl methoxycinnamate, sulfonic acid and phenylbenzimidazole. A new line of Olay Complete Radiance SPF 15 will begin roll out in March (5 (Also see "Oil Of Olay SPF 15 Color" - HBW Insight, 15 Nov, 1999.)). |