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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:  07/21/2006
 
Trade Name:  Anthelios SX Cream
 
Generic Name or Proper Name (*):  avobenzone; ecamsule; octocrylene
 
Indications Studied:  Prevention of sunburn and protection from UVA and UVB rays in children 6 months of age and older OTC
 
Label Changes Summary:  * Effectiveness extrapolated from adult studies * Safety studies included pediatric patients 6 months of age and older * Age range based on monograph * Deferred studies in children < 6 months of age * New active ingredient
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  LOreal USA
 
NNPS:  FALSE
 
Therapeutic Category:  Sunscreen
 
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