NDC 58443-0045

Panama Jack SPF 8

Oxtinoxate, 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: 58443-0045_7d78ed75-29b0-6fa3-e053-2991aa0a5b2c
• NDC: 58443-0045
• Product Type: Human Otc Drug
• Proprietary Name: Panama Jack SPF 8
• Generic Name: Oxtinoxate, And Oxybenzone
• Dosage Form: Spray
• Route of Administration: TOPICAL
• Marketing Start Date: 2012-01-10
• 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 58443-0045-4

237 mL in 1 BOTTLE (58443-0045-4)

• Marketing Start Date: 2012-01-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0045-4 [58443004504]

Panama Jack SPF 8 SPRAY

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-01-10

Drug Details

Active Ingredients

Ingredient	Strength
OCTINOXATE	19.8 mg/mL

OpenFDA Data

• SPL SET ID: 5779e99b-01f0-482c-8960-8de6a814e2f2
• Manufacturer:
  • Prime Enterprises, Inc.
• UNII:
  • 95OOS7VE0Y
  • 4Y5P7MUD51
• UPC Code:
  • 0045336026089

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

NDC	Brand Name	Generic Name
58443-0050	Panama Jack SPF 8	Panama Jack SPF 8
58443-0051	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
58443-0045	Panama Jack	Oxtinoxate, and Oxybenzone