"58443-0437-9" National Drug Code (NDC)

Australian Gold 3700 mL in 1 JUG (58443-0437-9)
(Prime Enterprises, Inc.)

NDC Code58443-0437-9
Package Description3700 mL in 1 JUG (58443-0437-9)
Product NDC58443-0437
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 Date20230804
Marketing Category NameOTC MONOGRAPH FINAL
Application NumberM020
ManufacturerPrime Enterprises, Inc.
Substance NameAVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Strength29.46; 98.2; 49.1; 49.1
Strength Unitmg/mL; mg/mL; mg/mL; mg/mL

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