NDC 58443-0289

Panama Jack SPF 4

Octocrylene

Panama Jack SPF 4 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Prime Enterprises Inc.. The primary component is Octocrylene.

• Product ID: 58443-0289_938d3f93-8d0b-f3d6-e053-2995a90af722
• NDC: 58443-0289
• Product Type: Human Otc Drug
• Proprietary Name: Panama Jack SPF 4
• Generic Name: Octocrylene
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-02-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Prime Enterprises Inc.
• Substance Name: OCTOCRYLENE
• Active Ingredient Strength: 19 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 58443-0289-4

177 mL in 1 BOTTLE (58443-0289-4)

• Marketing Start Date: 2019-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0289-4 [58443028904]

Panama Jack SPF 4 LOTION

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-02-01

Drug Details

Active Ingredients

Ingredient	Strength
OCTOCRYLENE	19.12 mg/mL

OpenFDA Data

• SPL SET ID: 938d3f93-8d0a-f3d6-e053-2995a90af722
• Manufacturer:
  • Prime Enterprises Inc.
• UNII:
  • 5A68WGF6WM
• UPC Code:
  • 0045336051043

NDC Crossover Matching brand name "Panama Jack SPF 4" or generic name "Octocrylene"

NDC	Brand Name	Generic Name
58443-0066	Panama Jack SPF 4	Panama Jack SPF 4
58443-0049	Panama Jack SPF 4	Panama Jack SPF 4
58443-0065	Panama Jack SPF 4	Panama Jack SPF 4
60289-015	AHAVA ACTIVE DEADSEA MINERALS	OCTOCRYLENE
60289-030	AHAVA ACTIVE DEADSEA MINERALS	OCTOCRYLENE
60289-031	AHAVA ACTIVE DEADSEA MINERALS	OCTOCRYLENE
60289-050	AHAVA ACTIVE DEADSEA MINERALS	OCTOCRYLENE
60289-051	AHAVA ACTIVE DEADSEA MINERALS	OCTOCRYLENE
70522-001	DT Collagen	Octocrylene
55301-005	Exchange Select Dark Tanning Sunscreen	OCTOCRYLENE
58443-0287	Panama Jack	Octocrylene
58443-0289	Panama Jack	Octocrylene
82736-015	Ultra Light Facial Sunscreen SPF 50	OCTOCRYLENE
71621-0011	UV Defense Pocket Sun Pad (Broad Spectrum, SPF30)	octocrylene
71621-0012	UV Defense Sun Block Tissues (BROAD SPECTRUM, SPF30)	octocrylene
74997-0015	W.SKIN TRIPLE CARE SUN	Octocrylene