NDC 58443-0051

Panama Jack SPF 8

Octinoxate, And Oxybenzone

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

• Product ID: 58443-0051_7d79203c-193f-b43d-e053-2a91aa0a5299
• NDC: 58443-0051
• Product Type: Human Otc Drug
• Proprietary Name: Panama Jack SPF 8
• Generic Name: Octinoxate, And Oxybenzone
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-01-25
• 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 58443-0051-4

177 mL in 1 BOTTLE (58443-0051-4)

• Marketing Start Date: 2013-01-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0051-4 [58443005104]

Panama Jack SPF 8 LOTION

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-01-25

Drug Details

Active Ingredients

Ingredient	Strength
OCTINOXATE	19.5 mg/mL

OpenFDA Data

• SPL SET ID: 7811ecfd-5618-47ea-9681-ad336c00590b
• Manufacturer:
  • Prime Enterprises, Inc.
• UNII:
  • 95OOS7VE0Y
  • 4Y5P7MUD51
• UPC Code:
  • 0045336051081

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