"58443-0501-4" National Drug Code (NDC)

Australian Gold 237 mL in 1 BOTTLE (58443-0501-4)
(Prime Enterprises Inc.)

NDC Code58443-0501-4
Package Description237 mL in 1 BOTTLE (58443-0501-4)
Product NDC58443-0501
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 Date20190703
Marketing Category NameOTC MONOGRAPH NOT FINAL
Application Numberpart352
ManufacturerPrime Enterprises Inc.
Substance NameAVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Strength29.79; 74.48; 49.65; 49.65
Strength Unitmg/mL; mg/mL; mg/mL; mg/mL

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