NDC 58443-0161

California Tan SPF 45 Sunscreen

Avobenzone, Homosalate, Octisalate, Octocrylene And Oxybenzone

California Tan SPF 45 Sunscreen is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Prime Enterprises Inc.. The primary component is Oxybenzone; Avobenzone; Homosalate; Octisalate; Octocrylene.

• Product ID: 58443-0161_40b92e12-8e19-4fd7-e054-00144ff88e88
• NDC: 58443-0161
• Product Type: Human Otc Drug
• Proprietary Name: California Tan SPF 45 Sunscreen
• Generic Name: Avobenzone, Homosalate, Octisalate, Octocrylene And Oxybenzone
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-11-11
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Prime Enterprises Inc.
• Substance Name: OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
• Active Ingredient Strength: 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58443-0161-3

133 mL in 1 TUBE (58443-0161-3)

• Marketing Start Date: 2013-11-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0161-3 [58443016103]

California Tan SPF 45 Sunscreen LOTION

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-11-11

Drug Details

Active Ingredients

Ingredient	Strength
OXYBENZONE	20 mg/mL

OpenFDA Data

• SPL SET ID: 40b92e12-8e18-4fd7-e054-00144ff88e88
• Manufacturer:
  • Prime Enterprises Inc.
• UNII:
  • G63QQF2NOX
  • 95OOS7VE0Y
  • 4X49Y0596W
  • 5A68WGF6WM
  • V06SV4M95S

NDC Crossover Matching brand name "California Tan SPF 45 Sunscreen" or generic name "Avobenzone, Homosalate, Octisalate, Octocrylene And Oxybenzone"

NDC	Brand Name	Generic Name
58443-0161	California Tan SPF 45 Sunscreen	California Tan SPF 45 Sunscreen
13630-0038	Aloe Up	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
13630-0039	Aloe Up	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
13630-0040	Aloe Up	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
13630-0018	Australian Gold	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
13630-0023	Australian Gold	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
13630-0025	Australian Gold	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
13630-0026	Australian Gold	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
11523-7431	Coppertone Kids Wet Protect SPF 50	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
11523-7423	Coppertone Ultra Guard SPF 30	avobenzone, homosalate, octisalate, octocrylene and oxybenzone
11523-7425	Coppertone Ultra Guard SPF 50	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
11523-7426	Coppertone Ultra Guard SPF 50	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
11523-7420	Coppertone Ultra Guard SPF 70	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
13630-0072	Raydiant by Australian Gold	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
13630-0050	SolMate	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
13630-0051	SOLMATE	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
13630-0056	SolMate	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
13630-0057	SolMate	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
13630-0058	SolMate	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
13630-0060	SolMate	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
13630-0049	SUNZEN	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
13630-0055	Sunzen	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
13630-0044	Ulta	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
13630-0069	Ulta	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
13630-0070	Ulta	Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone