<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
82757-001-01
</NDCCode>
<PackageDescription>
1 CONTAINER in 1 BOX (82757-001-01) / 20.24 g in 1 CONTAINER
</PackageDescription>
<NDC11Code>
82757-0001-01
</NDC11Code>
<ProductNDC>
82757-001
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Zinc Oxide 14.69%
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Sunscreen Spf 50
</NonProprietaryName>
<DosageFormName>
STICK
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20260923
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M020
</ApplicationNumber>
<LabelerName>
Dune Suncare
</LabelerName>
<SubstanceName>
ZINC OXIDE
</SubstanceName>
<StrengthNumber>
14.69
</StrengthNumber>
<StrengthUnit>
g/100g
</StrengthUnit>
<Pharm_Classes>
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-09-23
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260923
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>