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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
LOreal USA
NNPS:
FALSE'
Therapeutic Category:
Sunscreen
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