"58443-0382-3" National Drug Code (NDC)

Australian Gold 100 mL in 1 BOTTLE (58443-0382-3)
(Prime Enterprises, Inc.)

NDC Code58443-0382-3
Package Description100 mL in 1 BOTTLE (58443-0382-3)
Product NDC58443-0382
Product Type NameHUMAN OTC DRUG
Proprietary NameAustralian Gold
Proprietary Name SuffixSpf 30
Non-Proprietary NameAvobenzone, Homosalate, Octisalate, Octocrylene
Dosage FormLOTION
UsageTOPICAL
Start Marketing Date20201123
Marketing Category NameOTC MONOGRAPH FINAL
Application Numberpart352
ManufacturerPrime Enterprises, Inc.
Substance NameAVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Strength30.87; 77.175; 51.45; 51.45
Strength Unitmg/mL; mg/mL; mg/mL; mg/mL

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