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J&J supports BASF ingredient

Executive Summary

FDA should expedite review of BASF's Time & Extent Application for UVB absorber octyl triazone, marketed in Europe as Uvinul T-150, Johnson & Johnson says in an Oct. 7 letter to the agency. While J&J "has no experience with this ingredient, we are aware of the limited choices available for sunscreen actives," company states. BASF first petitioned FDA to designate octyl triazone a Category I sunscreen ingredient in November 1996, based on foreign marketing experience (1"The Rose Sheet" Dec. 2, 1996, p. 8). The ingredient has been marketed in Europe since 1989 and in Japan since 1996. FDA barred interim marketing of OTC drugs in the U.S. in its final rule on "material time, material extent" criteria, and noted pending citizen petitions from sunscreen ingredient suppliers could be converted to TEAs for agency consideration of monograph eligibility (2"The Rose Sheet" Jan. 29, 2002, p. 8)...
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FDA “Material Time, Material Extent” May Be Cloudy For Sunscreens
Octyl triazone inclusion in sunscreen TFM based on foreign use data sought by BASF.
Octyl triazone inclusion in sunscreen TFM based on foreign use data sought by BASF.
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