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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  03/31/2008
Trade Name:  Lancôme UV Expert 40 La Roche-Posay Anthelios 40 Vichy Capital Soleil 40
Generic Name or Proper Name (*):  avobenzone, ecamsule, octocrylene, titanium dioxide cream
Indications Studied:  Sunscreen OTC
Label Changes Summary:  * Effectiveness extrapolated from adult studies * Safety studies included pediatric patients 6 months of age and older * Age range based on standards established in over-the counter monograph for sunscreens * New active ingredient *
Sponsor:  LOreal USA
Therapeutic Category:  Sunscreen