<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
85455-100-61
</NDCCode>
<PackageDescription>
7.5 mL in 1 PACKET (85455-100-61)
</PackageDescription>
<NDC11Code>
85455-0100-61
</NDC11Code>
<ProductNDC>
85455-100
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Burnd
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Homosalate, Octinoxate, Zinc Oxide
</NonProprietaryName>
<DosageFormName>
LOTION
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20250409
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M020
</ApplicationNumber>
<LabelerName>
BURND LLC
</LabelerName>
<SubstanceName>
HOMOSALATE; OCTINOXATE; ZINC OXIDE
</SubstanceName>
<StrengthNumber>
8; 7.5; 8.1
</StrengthNumber>
<StrengthUnit>
g/100mL; g/100mL; g/100mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-05
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250409
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>