<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
61354-117-02
</NDCCode>
<PackageDescription>
1 CUP in 1 CARTON (61354-117-02) / 100 mg in 1 CUP (61354-117-01)
</PackageDescription>
<NDC11Code>
61354-0117-02
</NDC11Code>
<ProductNDC>
61354-117
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Powder
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Titanium Dioxide
</NonProprietaryName>
<DosageFormName>
POWDER
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20231027
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M020
</ApplicationNumber>
<LabelerName>
Oxygen Development LLC
</LabelerName>
<SubstanceName>
FERRIC OXIDE RED; TITANIUM DIOXIDE
</SubstanceName>
<StrengthNumber>
1.75; 10
</StrengthNumber>
<StrengthUnit>
mg/100mg; mg/100mg
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-09-09
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20231027
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>