SPF, critical wavelength tests in lieu of minimum active reg for combos urged -- P&G.

Executive Summary

SPF, CRITICAL WAVELENGTH TEST USE TO SHOW "SIGNIFICANT CONTRIBUTION" of individual active ingredients in products containing a combination of actives urged by Procter & Gamble in a citizen petition submitted to FDA May 26. The tests would be used in lieu of the OTC sunscreen tentative final monograph requirement that products be formulated using active ingredients at a minimum concentration level. Using the SPF and/or critical wavelength method to demonstrate that each ingredient contributes to increased product efficacy would allow FDA to abolish the minimum concentration level requirements, P&G maintains.