"58443-0035-4" National Drug Code (NDC)

Australian Gold 237 mL in 1 BOTTLE, WITH APPLICATOR (58443-0035-4)
(Prime Enterprises, Inc.)

NDC Code58443-0035-4
Package Description237 mL in 1 BOTTLE, WITH APPLICATOR (58443-0035-4)
Product NDC58443-0035
Product Type NameHUMAN OTC DRUG
Proprietary NameAustralian Gold
Proprietary Name SuffixBroad Spectrum Spf 8
Non-Proprietary NameAvobenzone, Octisalate, Octocrylene, And Oxybenzone
Dosage FormLOTION
UsageTOPICAL
Start Marketing Date20131014
Marketing Category NameOTC MONOGRAPH FINAL
Application Numberpart352
ManufacturerPrime Enterprises, Inc.
Substance NameAVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Strength9.9; 29.7; 8.4; 9.9
Strength Unitmg/mL; mg/mL; mg/mL; mg/mL

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