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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 *
 
PREA(P):  P
 
Sponsor:  LOreal USA
 
NNPS:  FALSE
 
Therapeutic Category:  Sunscreen
 
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