<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70453-001-01
</NDCCode>
<PackageDescription>
1 BOTTLE in 1 BOX (70453-001-01) / 50 mL in 1 BOTTLE
</PackageDescription>
<NDC11Code>
70453-0001-01
</NDC11Code>
<ProductNDC>
70453-001
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Protect And Prime Broad Spectrum Spf30
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Avobenzone, Octinoxate, Octocrylene, Oxybenzone
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20160203
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M020
</ApplicationNumber>
<LabelerName>
Emma Hardie Ltd
</LabelerName>
<SubstanceName>
AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE
</SubstanceName>
<StrengthNumber>
30; 75; 100; 60
</StrengthNumber>
<StrengthUnit>
mg/mL; mg/mL; mg/mL; mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2023-11-11
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20160203
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>