NDC 58443-0050

Panama Jack SPF 8

Octinoxate, And Oxybenzone

Panama Jack SPF 8 is a Topical Spray in the Human Otc Drug category. It is labeled and distributed by Prime Enterprises, Inc.. The primary component is Octinoxate; Oxybenzone.

Product ID58443-0050_7d791cb8-f58e-cd8d-e053-2a91aa0acab9
NDC58443-0050
Product TypeHuman Otc Drug
Proprietary NamePanama Jack SPF 8
Generic NameOctinoxate, And Oxybenzone
Dosage FormSpray
Route of AdministrationTOPICAL
Marketing Start Date2013-02-18
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NamePrime Enterprises, Inc.
Substance NameOCTINOXATE; OXYBENZONE
Active Ingredient Strength20 mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58443-0050-4

237 mL in 1 BOTTLE (58443-0050-4)
Marketing Start Date2013-02-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58443-0050-4 [58443005004]

Panama Jack SPF 8 SPRAY
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-02-18

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE19.5 mg/mL

OpenFDA Data

SPL SET ID:081dbd5a-0c39-433e-9c57-95c0e8754908
Manufacturer
UNII
UPC Code
  • 0045336026089