<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
84803-117-05
</NDCCode>
<PackageDescription>
1 TUBE in 1 CARTON (84803-117-05) / 5 mL in 1 TUBE
</PackageDescription>
<NDC11Code>
84803-0117-05
</NDC11Code>
<ProductNDC>
84803-117
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Ultra Violette Fave Screen Broad Spectrum Spf 50
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Avobenzone, Bemotrizinol, Octisalate
</NonProprietaryName>
<DosageFormName>
LOTION
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20260901
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M020
</ApplicationNumber>
<LabelerName>
Grace and Fire USA
</LabelerName>
<SubstanceName>
AVOBENZONE; BEMOTRIZINOL; OCTISALATE
</SubstanceName>
<StrengthNumber>
.3; .5; .5
</StrengthNumber>
<StrengthUnit>
g/10mL; g/10mL; g/10mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-09-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260901
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>