"58443-0361-4" National Drug Code (NDC)

Australian Gold 237 mL in 1 BOTTLE (58443-0361-4)
(Prime Enterprises Inc.)

NDC Code58443-0361-4
Package Description237 mL in 1 BOTTLE (58443-0361-4)
Product NDC58443-0361
Product Type NameHUMAN OTC DRUG
Proprietary NameAustralian Gold
Proprietary Name SuffixSpf 30 Sport Ultra Chill
Non-Proprietary NameOctisalate, Avobenzone, Homosalate, Octocrylene
Dosage FormLOTION
UsageTOPICAL
Start Marketing Date20191014
Marketing Category NameOTC MONOGRAPH NOT FINAL
Application Numberpart352
ManufacturerPrime Enterprises Inc.
Substance NameHOMOSALATE; OCTOCRYLENE; AVOBENZONE; OCTISALATE
Strength75.68; 50.45; 30.27; 50.45
Strength Unitmg/mL; mg/mL; mg/mL; mg/mL

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