<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
84489-100-34
</NDCCode>
<PackageDescription>
1 BOTTLE, PUMP in 1 CARTON (84489-100-34) / 100 mL in 1 BOTTLE, PUMP
</PackageDescription>
<NDC11Code>
84489-0100-34
</NDC11Code>
<ProductNDC>
84489-100
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Spf 50 Florida Sun Defense
</ProprietaryName>
<ProprietaryNameSuffix>
Broad Spectrum Spf 50 Sunscreen Body Oil
</ProprietaryNameSuffix>
<NonProprietaryName>
Homosalate, Octisalate, Octocrylene
</NonProprietaryName>
<DosageFormName>
OIL
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20250703
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M020
</ApplicationNumber>
<LabelerName>
Naples Soap Company, Inc.
</LabelerName>
<SubstanceName>
HOMOSALATE; OCTISALATE; OCTOCRYLENE
</SubstanceName>
<StrengthNumber>
10; 5; 10
</StrengthNumber>
<StrengthUnit>
g/100mL; g/100mL; g/100mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-02-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250703
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>