"58443-0218-4" National Drug Code (NDC)

Australian Gold 237 mL in 1 BOTTLE (58443-0218-4)
(Prime Enterprises Inc.)

NDC Code58443-0218-4
Package Description237 mL in 1 BOTTLE (58443-0218-4)
Product NDC58443-0218
Product Type NameHUMAN OTC DRUG
Proprietary NameAustralian Gold
Proprietary Name SuffixBaby Spf 50 Sunscreen
Non-Proprietary NameHomosalate, Octinoxate, Octisalate And Titanium Dioxide
Dosage FormLOTION
UsageTOPICAL
Start Marketing Date20151102
Marketing Category NameOTC MONOGRAPH FINAL
Application Numberpart352
ManufacturerPrime Enterprises Inc.
Substance NameHOMOSALATE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
Strength102; 76.5; 51; 25.5
Strength Unitmg/mL; mg/mL; mg/mL; mg/mL

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