"58443-0308-3" National Drug Code (NDC)

Pelagic 88.7 mL in 1 BOTTLE (58443-0308-3)
(Prime Enterprises Inc.)

NDC Code58443-0308-3
Package Description88.7 mL in 1 BOTTLE (58443-0308-3)
Product NDC58443-0308
Product Type NameHUMAN OTC DRUG
Proprietary NamePelagic
Proprietary Name SuffixBroad Spectrum Spf 50 Sunscreen
Non-Proprietary NameTitanium Dioxide, Zinc Oxide
Dosage FormLOTION
UsageTOPICAL
Start Marketing Date20191024
Marketing Category NameOTC MONOGRAPH FINAL
Application Numberpart352
ManufacturerPrime Enterprises Inc.
Substance NameTITANIUM DIOXIDE; ZINC OXIDE
Strength44.6; 39.6
Strength Unitmg/mL; mg/mL

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