NDC 58443-0082

California Tan BROAD SPECTRUM SPF 8

Avobenzone, Octocrylene, And Oxybenzone

California Tan BROAD SPECTRUM 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 Avobenzone; Octocrylene; Oxybenzone.

• Product ID: 58443-0082_7d7ba15a-66f8-72cd-e053-2991aa0ac3b5
• NDC: 58443-0082
• Product Type: Human Otc Drug
• Proprietary Name: California Tan BROAD SPECTRUM SPF 8
• 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 58443-0082-3

133 mL in 1 TUBE (58443-0082-3)

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

NDC SPL Data Element Entries

NDC 58443-0082-3 [58443008203]

California Tan BROAD SPECTRUM SPF 8 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	4.9 mg/mL

OpenFDA Data

• SPL SET ID: eac90a17-b7b3-4ef1-84b5-f3a4ffe11ac7
• Manufacturer:
  • Prime Enterprises, Inc.
• UNII:
  • G63QQF2NOX
  • 95OOS7VE0Y
  • 5A68WGF6WM

NDC Crossover Matching brand name "California Tan BROAD SPECTRUM SPF 8" or generic name "Avobenzone, Octocrylene, And Oxybenzone"

NDC	Brand Name	Generic Name
13630-0061	California Tan Broad Spectrum SPF 8	California Tan Broad Spectrum SPF 8
13630-0008	Australian Gold	Avobenzone, Octocrylene, and Oxybenzone
13630-0065	Australian Gold	Avobenzone, Octocrylene, and Oxybenzone
58443-0015	Australian Gold	Avobenzone, Octocrylene, and Oxybenzone
58443-0021	Australian Gold	Avobenzone, Octocrylene, and Oxybenzone
58443-0022	Australian Gold	Avobenzone, Octocrylene, and Oxybenzone
58443-0023	Australian Gold	Avobenzone, Octocrylene, and Oxybenzone
58443-0026	Australian Gold	Avobenzone, Octocrylene, and Oxybenzone
58443-0029	Australian Gold	Avobenzone, Octocrylene, and Oxybenzone
58443-0034	Australian Gold	Avobenzone, Octocrylene, and Oxybenzone
58443-0220	Australian Gold	Avobenzone, octocrylene, and oxybenzone
58443-0082	California Tan	Avobenzone, Octocrylene, and Oxybenzone
0259-3192	Mederma	AVOBENZONE, OCTOCRYLENE, and OXYBENZONE
73302-200	Mederma Scar Cream	AVOBENZONE, OCTOCRYLENE, and OXYBENZONE
73302-205	Mederma Scar Cream	AVOBENZONE, OCTOCRYLENE, and OXYBENZONE