NDC 58443-0076

Australian Gold BROAD SPECTRUM SPF 4

Avobenzone, Octocrylene And Oxybenzone

Australian Gold BROAD SPECTRUM SPF 4 is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Prime Enterprises, Inc.. The primary component is Avobenzone; Octocrylene; Oxybenzone.

• Product ID: 58443-0076_7d7b5317-d97b-0e6c-e053-2a91aa0a763d
• NDC: 58443-0076
• Product Type: Human Otc Drug
• Proprietary Name: Australian Gold BROAD SPECTRUM SPF 4
• Generic Name: Avobenzone, Octocrylene And Oxybenzone
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-11-21
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Prime Enterprises, Inc.
• Substance Name: AVOBENZONE; OCTOCRYLENE; OXYBENZONE
• Active Ingredient Strength: 10 mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58443-0076-4

237 mL in 1 BOTTLE (58443-0076-4)

• Marketing Start Date: 2013-11-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0076-4 [58443007604]

Australian Gold BROAD SPECTRUM SPF 4 GEL

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-11-21

Drug Details

Active Ingredients

Ingredient	Strength
AVOBENZONE	9.8 mg/mL

OpenFDA Data

• SPL SET ID: c5ad40de-49ad-4e59-b601-fccffd2fc298
• Manufacturer:
  • Prime Enterprises, Inc.
• UNII:
  • G63QQF2NOX
  • 95OOS7VE0Y
  • 5A68WGF6WM
• UPC Code:
  • 0054402250341

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

NDC	Brand Name	Generic Name
13630-0008	Australian Gold Broad Spectrum SPF 4	Australian Gold Broad Spectrum SPF 4
58443-0034	Australian Gold Broad Spectrum SPF 4	Australian Gold Broad Spectrum SPF 4
58443-0022	Australian Gold Broad Spectrum SPF 4	Australian Gold Broad Spectrum SPF 4
58443-0021	Australian Gold Broad Spectrum SPF 4	Australian Gold Broad Spectrum SPF 4
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