NDC 58443-0080

California Tan BROAD SPECTRUM SPF 4

Avobenzone, Octocrylene And Oxybenzone

California Tan BROAD SPECTRUM 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 Avobenzone; Octocrylene; Oxybenzone.

• Product ID: 58443-0080_7d7ba535-9820-a281-e053-2a91aa0a73ed
• NDC: 58443-0080
• Product Type: Human Otc Drug
• Proprietary Name: California Tan BROAD SPECTRUM SPF 4
• Generic Name: Avobenzone, Octocrylene And Oxybenzone
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-12-09
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Prime Enterprises, Inc.
• Substance Name: AVOBENZONE; OCTOCRYLENE; OXYBENZONE
• Active Ingredient Strength: 5 mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58443-0080-3

133 mL in 1 TUBE (58443-0080-3)

• Marketing Start Date: 2013-12-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0080-3 [58443008003]

California Tan BROAD SPECTRUM SPF 4 LOTION

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-12-09

Drug Details

Active Ingredients

Ingredient	Strength
AVOBENZONE	4.79 mg/mL

OpenFDA Data

• SPL SET ID: 1a4ff0a2-239f-432d-8be1-d68aeca26174
• Manufacturer:
  • Prime Enterprises, Inc.
• UNII:
  • G63QQF2NOX
  • 95OOS7VE0Y
  • 5A68WGF6WM

NDC Crossover Matching brand name "California Tan BROAD SPECTRUM SPF 4" or generic name "Avobenzone, Octocrylene And Oxybenzone"

NDC	Brand Name	Generic Name
13630-0019	Australian Gold	Avobenzone, Octocrylene and Oxybenzone
58443-0076	Australian Gold	Avobenzone, Octocrylene and Oxybenzone
13630-0061	California Tan	Avobenzone, Octocrylene and Oxybenzone
58443-0080	California Tan	Avobenzone, Octocrylene and Oxybenzone
13630-0048	SOLMATE	Avobenzone, Octocrylene and Oxybenzone
13630-0047	Suntone	Avobenzone, Octocrylene and Oxybenzone