<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
83119-245-50
</NDCCode>
<PackageDescription>
1 BOTTLE in 1 BOX (83119-245-50) / 30 g in 1 BOTTLE
</PackageDescription>
<NDC11Code>
83119-0245-50
</NDC11Code>
<ProductNDC>
83119-245
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Unid Sea Fennel Tinted Sun Protector
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Titanium Dioxide
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20251218
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M020
</ApplicationNumber>
<LabelerName>
Sage Pharmaceuticals Inc
</LabelerName>
<SubstanceName>
TITANIUM DIOXIDE
</SubstanceName>
<StrengthNumber>
8.28
</StrengthNumber>
<StrengthUnit>
g/100g
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-24
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251218
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>