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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 256-0321142-3/1/8

Manufacturer FEI3008805335
Manufacturer NameMon Deconatur Sl  
Manufacturer Address line 1Cl Cortit No 16  
Manufacturer Address line 2  
Manufacturer's CityBarcelona  
Manufacturer Province/State  
Manufacturer Country/AreaSpain  
Product Code53LD99  
Importer's Product DescriptionSUN CREAM 50ML  
Refusal Date26-Sep-2012  
FDA DistrictSJN-DO  
Entry/doc/line/sfx 256-0321142-3/1/8
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.