p. L'Oreal request to increase concentration of avobenzone to 5...

p. L'Oreal request to increase concentration of avobenzone to 5 percent. Avobenzone is currently listed in the Stayed 1999 Final Monograph at concentrations up to 3 percent. As described earlier, in 2009 FDA received a citizen petition from L'Oreal requesting, among other things, that we amend the sunscreen monograph to increase the allowable level of avobenzone to 5 percent (L'Oreal Petition at 1). In the Stayed 1999 Final Monograph, the Agency determined that avobenzone at concentrations up to 3 percent is an effective sunscreen active ingredient. We now likewise conclude that the record contains sufficient information to satisfy the effectiveness prong of the GRASE standard for sunscreens containing avobenzone at concentrations up to 5 percent.As described above, data submitted with that L'Oreal Petition were sufficient to establish that avobenzone at a concentration of up to 5 percent has a favorable safety profile with respect to potential irritation, sensitization, and photosafety. To support a finding that avobenzone at concentrations up to 5 percent is GRASE for use in sunscreens, however, FDA expects that a MUsT evaluating the transdermal absorption of avobenzone up to 5 percent, as well as dermal carcinogenicity studies and toxicokinetic data for avobenzone at a concentration of at least 5 percent, will also be needed. Depending on the outcome of the MUsT, we may also need systemic carcinogenicity data and additional DART studies, including fertility and early embryonic development, and pre- and postnatal development studies in rats for avobenzone at 5 percent. The record does not currently include any of these data. However, if FDA were to receive sufficient data to support a positive GRASE finding for avobenzone up to 5 percent, we would expect to include avobenzone at this percentage in a final sunscreen monograph.