<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
85396-202-50
</NDCCode>
<PackageDescription>
53 g in 1 BOTTLE, PUMP (85396-202-50)
</PackageDescription>
<NDC11Code>
85396-0202-50
</NDC11Code>
<ProductNDC>
85396-202
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Acnefix Non-tinted Mineral Sunscreen
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Titanium Dioxide, Zinc Oxide
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20221116
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M020
</ApplicationNumber>
<LabelerName>
ACNEFIX INC.
</LabelerName>
<SubstanceName>
TITANIUM DIOXIDE; ZINC OXIDE
</SubstanceName>
<StrengthNumber>
80; 38
</StrengthNumber>
<StrengthUnit>
mg/g; mg/g
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-04-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20221116
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>