"58443-0587-8" National Drug Code (NDC)

Australian Gold 3700 mL in 1 BOTTLE (58443-0587-8)
(Prime Enterprises, Inc.)

NDC Code58443-0587-8
Package Description3700 mL in 1 BOTTLE (58443-0587-8)
Product NDC58443-0587
Product Type NameHUMAN OTC DRUG
Proprietary NameAustralian Gold
Proprietary Name SuffixBroad Spectrum Spf 50
Non-Proprietary NameAvobenzone, Homosalate, Octisalate, Octocrylene
Dosage FormLOTION
UsageTOPICAL
Start Marketing Date20201211
Marketing Category NameOTC MONOGRAPH FINAL
Application NumberM020
ManufacturerPrime Enterprises, Inc.
Substance NameAVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Strength29.94; 99.8; 49.9; 49.9
Strength Unitg/mL; g/mL; g/mL; g/mL

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