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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 ARM-0068724-0/9/1/B

Manufacturer FEI3010139627
Manufacturer NameEminence Organic skin Care  
Manufacturer Address line 1300 530 west Broadway  
Manufacturer Address line 2  
Manufacturer's CityVancouver  
Manufacturer Province/StateBC  
Manufacturer Country/AreaCanada  
Product Code53LC99  
Importer's Product DescriptionMONOI AGE CORRECTIVE CREAM .5 OZ  
Refusal Date27-Mar-2013  
FDA DistrictSEA-DO  
Entry/doc/line/sfx ARM-0068724-0/9/1/B
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.  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.