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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 W24-0314162-5/1/1

Manufacturer FEI3005246013
Manufacturer NameSwallowfield Plc  
Manufacturer Address line 1Station Road  
Manufacturer Address line 2  
Manufacturer's CityWellington  
Manufacturer Province/StateSomerset  
Manufacturer Country/AreaUnited Kingdom  
Product Code53MA02  
Importer's Product DescriptionSUNCARE- MOISTERIZER  
Refusal Date03-Apr-2013  
FDA DistrictCHI-DO  
Entry/doc/line/sfx W24-0314162-5/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COSM COLOR   601(e), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).