"58443-0097-3" National Drug Code (NDC)

California Tan 133 mL in 1 TUBE (58443-0097-3)
(Prime Enterprises, Inc.)

NDC Code58443-0097-3
Package Description133 mL in 1 TUBE (58443-0097-3)
Product NDC58443-0097
Product Type NameHUMAN OTC DRUG
Proprietary NameCalifornia Tan
Proprietary Name SuffixBroad Spectrum Spf 45
Non-Proprietary NameAvobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone
Dosage FormLOTION
UsageTOPICAL
Start Marketing Date20130404
Marketing Category NameOTC MONOGRAPH FINAL
Application Numberpart352
ManufacturerPrime Enterprises, Inc.
Substance NameAVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Strength29.9; 99.8; 49.9; 27.5; 19.9
Strength Unitmg/mL; mg/mL; mg/mL; mg/mL; mg/mL

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