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)