"58443-0630-3" National Drug Code (NDC)

Australian Gold 100 mL in 1 TUBE (58443-0630-3)
(Prime Enterprises, Inc.)

NDC Code58443-0630-3
Package Description100 mL in 1 TUBE (58443-0630-3)
Product NDC58443-0630
Product Type NameHUMAN OTC DRUG
Proprietary NameAustralian Gold
Proprietary Name SuffixSpf 30
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
Strength30.09; 75.23; 50.15; 50.15
Strength Unitmg/mL; mg/mL; mg/mL; mg/mL

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