<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
63354-861-61
</NDCCode>
<PackageDescription>
14.2 g in 1 CARTON (63354-861-61)
</PackageDescription>
<NDC11Code>
63354-0861-61
</NDC11Code>
<ProductNDC>
63354-861
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Hawaiian Tropic
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Homosalate,octocrylene,octisalate,avobenzone
</NonProprietaryName>
<DosageFormName>
STICK
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20251001
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M020
</ApplicationNumber>
<LabelerName>
Edgewell Personal Care Brands LLC
</LabelerName>
<SubstanceName>
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
</SubstanceName>
<StrengthNumber>
2.7; 9; 4.5; 9
</StrengthNumber>
<StrengthUnit>
g/100g; g/100g; g/100g; g/100g
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-10-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251001
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>