"58443-0197-3" National Drug Code (NDC)

Australian Gold 50 mL in 1 BOTTLE (58443-0197-3)
(Prime Enterprises Inc.)

NDC Code58443-0197-3
Package Description50 mL in 1 BOTTLE (58443-0197-3)
Product NDC58443-0197
Product Type NameHUMAN OTC DRUG
Proprietary NameAustralian Gold
Proprietary Name SuffixBroad Spectrum Spf 30 X-treme Sport Sunscreen
Non-Proprietary NameAvobenzone, Homosalate, Octisalate, Octocrylene And Oxybenzone
Dosage FormLOTION
UsageTOPICAL
Start Marketing Date20151007
Marketing Category NameOTC MONOGRAPH FINAL
Application Numberpart352
ManufacturerPrime Enterprises Inc.
Substance NameAVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Strength29.7; 74.3; 49.5; 27.2; 19.8
Strength Unitmg/mL; mg/mL; mg/mL; mg/mL; mg/mL

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