<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
35192-044-01
</NDCCode>
<PackageDescription>
61 g in 1 TUBE (35192-044-01)
</PackageDescription>
<NDC11Code>
35192-0044-01
</NDC11Code>
<ProductNDC>
35192-044
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Mineral Sunscreen
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Zinc Oxide
</NonProprietaryName>
<DosageFormName>
EMULSION
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20210815
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M020
</ApplicationNumber>
<LabelerName>
CA-Botana International
</LabelerName>
<SubstanceName>
ZINC OXIDE
</SubstanceName>
<StrengthNumber>
12.81
</StrengthNumber>
<StrengthUnit>
g/12.81g
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-18
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20210815
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>