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P&G Avobenzone Combo Data Demonstrate Broad Spectrum Protection - FDA

This article was originally published in The Tan 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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P&G on UVA

Procter & Gamble submits additional UVA efficacy data supporting the addition of avobenzone combined with either 2-pherrylbenzimidazole-5 sulfonic acid (PBSA) or zinc oxide in the final sunscreen monograph. The in vivo data show 1.5% PBSA with 3% avobenzone had a protection factor of 3.6, versus 1.4 for PBSA alone. Similarly, 4% zinc oxide combined with 3% avobenzone had a 5.6 protection factor compared to 2.3 with zinc oxide alone. P&G originally submitted safety data on the ingredients after a Jan. 27 "feedback" meeting with the agency ("The Tan Sheet" March 15, In Brief). FDA found the data insufficient ("The Tan Sheet" April 26, p. 9)

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