"58443-0456-2" National Drug Code (NDC)

Australian Gold 10 mL in 1 BOTTLE (58443-0456-2)
(Prime Enterprises Inc.)

NDC Code58443-0456-2
Package Description10 mL in 1 BOTTLE (58443-0456-2)
Product NDC58443-0456
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 Date20200326
Marketing Category NameOTC MONOGRAPH NOT FINAL
Application Numberpart352
ManufacturerPrime Enterprises Inc.
Substance NameAVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Strength29.73; 74.33; 49.55; 49.55
Strength Unitmg/mL; mg/mL; mg/mL; mg/mL

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