NDC 58443-0052

Panama Jack SPF 15

Octinoxate, Octisalate And Oxybenzone

Panama Jack SPF 15 is a Topical Spray in the Human Otc Drug category. It is labeled and distributed by Prime Enterprises, Inc.. The primary component is Octinoxate; Octisalate; Oxybenzone.

• Product ID: 58443-0052_7d791848-dd7a-a47b-e053-2a91aa0ab43a
• NDC: 58443-0052
• Product Type: Human Otc Drug
• Proprietary Name: Panama Jack SPF 15
• Generic Name: Octinoxate, Octisalate And Oxybenzone
• Dosage Form: Spray
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-02-25
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Prime Enterprises, Inc.
• Substance Name: OCTINOXATE; OCTISALATE; OXYBENZONE
• Active Ingredient Strength: 48 mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58443-0052-4

177 mL in 1 BOTTLE (58443-0052-4)

• Marketing Start Date: 2013-02-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0052-4 [58443005204]

Panama Jack SPF 15 SPRAY

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-02-25

Drug Details

Active Ingredients

Ingredient	Strength
OCTINOXATE	48.4 mg/mL

OpenFDA Data

• SPL SET ID: e28f38a6-f4b5-44fc-8ad4-8b76b72ed327
• Manufacturer:
  • Prime Enterprises, Inc.
• UNII:
  • 95OOS7VE0Y
  • 4X49Y0596W
  • 4Y5P7MUD51
• UPC Code:
  • 0045336051159

NDC Crossover Matching brand name "Panama Jack SPF 15" or generic name "Octinoxate, Octisalate And Oxybenzone"

NDC	Brand Name	Generic Name
13630-0030	Panama Jack SPF 15	Panama Jack SPF 15
58443-0055	Panama Jack SPF 15	Panama Jack SPF 15
58443-0046	Panama Jack SPF 15	Panama Jack SPF 15
58443-0052	Panama Jack	Octinoxate, Octisalate and Oxybenzone
0187-5500	Purpose	Octinoxate, Octisalate and Oxybenzone
24208-001	PURPOSE	Octinoxate, Octisalate and Oxybenzone