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 ID: 58443-0050_7d791cb8-f58e-cd8d-e053-2a91aa0acab9
• NDC: 58443-0050
• Product Type: Human Otc Drug
• Proprietary Name: Panama Jack SPF 8
• Generic Name: Octinoxate, And Oxybenzone
• Dosage Form: Spray
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-02-18
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Prime Enterprises, Inc.
• Substance Name: OCTINOXATE; OXYBENZONE
• Active Ingredient Strength: 20 mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58443-0050-4

237 mL in 1 BOTTLE (58443-0050-4)

• Marketing Start Date: 2013-02-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0050-4 [58443005004]

Panama Jack SPF 8 SPRAY

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-02-18

Drug Details

Active Ingredients

Ingredient	Strength
OCTINOXATE	19.5 mg/mL

OpenFDA Data

• SPL SET ID: 081dbd5a-0c39-433e-9c57-95c0e8754908
• Manufacturer:
  • Prime Enterprises, Inc.
• UNII:
  • 95OOS7VE0Y
  • 4Y5P7MUD51
• UPC Code:
  • 0045336026089

NDC Crossover Matching brand name "Panama Jack SPF 8" or generic name "Octinoxate, And Oxybenzone"

NDC	Brand Name	Generic Name
58443-0045	Panama Jack SPF 8	Panama Jack SPF 8
58443-0064	Panama Jack SPF 8	Panama Jack SPF 8
58443-0282	Panama Jack SPF 8	Panama Jack SPF 8
13630-0174	Panama Jack SPF 8	Panama Jack SPF 8
58443-0050	Panama Jack	Octinoxate, and Oxybenzone
58443-0051	Panama Jack	Octinoxate, and Oxybenzone