"58443-0564-8" National Drug Code (NDC)

Panama Jack 1000 mL in 1 BOTTLE (58443-0564-8)
(Prime Enterprises Inc.)

NDC Code58443-0564-8
Package Description1000 mL in 1 BOTTLE (58443-0564-8)
Product NDC58443-0564
Product Type NameHUMAN OTC DRUG
Proprietary NamePanama Jack
Proprietary Name SuffixBroad Spectrum Spf 50
Non-Proprietary NameAvobenzone, Homosalate, Octisalate, Octocrylene
Dosage FormLOTION
UsageTOPICAL
Start Marketing Date20220210
Marketing Category NameOTC MONOGRAPH FINAL
Application NumberM020
ManufacturerPrime Enterprises Inc.
Substance NameAVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Strength29.07; 96.9; 48.45; 48.45
Strength Unitmg/mL; mg/mL; mg/mL; mg/mL

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