"58443-0031-4" National Drug Code (NDC)

Australian Gold 177 mL in 1 TUBE (58443-0031-4)
(Prime Enterprises, Inc.)

NDC Code58443-0031-4
Package Description177 mL in 1 TUBE (58443-0031-4)
Product NDC58443-0031
Product Type NameHUMAN OTC DRUG
Proprietary NameAustralian Gold
Proprietary Name SuffixBroad Spectrum Spf 30
Non-Proprietary NameAvobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone
Dosage FormLOTION
UsageTOPICAL
Start Marketing Date20130729
Marketing Category NameOTC MONOGRAPH FINAL
Application Numberpart352
ManufacturerPrime Enterprises, Inc.
Substance NameAVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Strength19.8; 74; 49.4; 27.1; 19.8
Strength Unitmg/mL; mg/mL; mg/mL; mg/mL; mg/mL

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