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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal 112-4739475-7/1/1

Manufacturer FEI3007383501
Manufacturer NameNaolys  
Manufacturer Address line 186 Route D'Arcachon  
Manufacturer Address line 2  
Manufacturer's CityCestas  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LC99  
Importer's Product Description868876147911 SUN PROTECT SKIN CREAM  
Refusal Date05-Dec-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-4739475-7/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COSMETLBLG   5(c)(3)(B); 801(a)(3) Misbranding   It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.