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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 112-5901109-1/1/11/B

Manufacturer FEI3009218787
Manufacturer NameSunmaxx Sp-Gmbh & Co Kg  
Manufacturer Address line 1Carl-Friedrich-Gauss-Str 11  
Manufacturer Address line 2  
Manufacturer's CityPulheim  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code53MD01  
Importer's Product Description876397579472 TANNING LOTION  
Refusal Date30-Mar-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-5901109-1/1/11/B
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.  
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).