NDC 58443-0075

Australian Gold BROAD SPECTRUM SPF 8

Avobenzone, Octisalate, Octocrylene And Oxybenzone

Australian Gold BROAD SPECTRUM SPF 8 is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Prime Enterprises, Inc.. The primary component is Avobenzone; Octisalate; Octocrylene; Oxybenzone.

• Product ID: 58443-0075_7d7a89b4-e2e9-6b3c-e053-2a91aa0a621b
• NDC: 58443-0075
• Product Type: Human Otc Drug
• Proprietary Name: Australian Gold BROAD SPECTRUM SPF 8
• Generic Name: Avobenzone, Octisalate, Octocrylene And Oxybenzone
• Dosage Form: Gel
• 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: AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
• Active Ingredient Strength: 8 mg/mL; mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58443-0075-4

237 mL in 1 BOTTLE (58443-0075-4)

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

NDC SPL Data Element Entries

NDC 58443-0075-4 [58443007504]

Australian Gold BROAD SPECTRUM SPF 8 GEL

• 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
AVOBENZONE	8.4 mg/mL

OpenFDA Data

• SPL SET ID: 562b388e-f1d1-40e7-919c-fa0bc019572b
• Manufacturer:
  • Prime Enterprises, Inc.
• UNII:
  • G63QQF2NOX
  • 95OOS7VE0Y
  • 4X49Y0596W
  • 5A68WGF6WM
• UPC Code:
  • 0054402260944

NDC Crossover Matching brand name "Australian Gold BROAD SPECTRUM SPF 8" or generic name "Avobenzone, Octisalate, Octocrylene And Oxybenzone"

NDC	Brand Name	Generic Name
13630-0065	Australian Gold Broad Spectrum SPF 8	Australian Gold Broad Spectrum SPF 8
13630-0020	Australian Gold Broad Spectrum SPF 8	Australian Gold Broad Spectrum SPF 8
58443-0023	Australian Gold Broad Spectrum SPF 8	Australian Gold Broad Spectrum SPF 8
58443-0035	Australian Gold Broad Spectrum SPF 8	Australian Gold Broad Spectrum SPF 8
58443-0015	Australian Gold Broad Spectrum SPF 8	Australian Gold Broad Spectrum SPF 8
58443-0029	Australian Gold Broad Spectrum SPF 8	Australian Gold Broad Spectrum SPF 8
58443-0026	Australian Gold Broad Spectrum SPF 8	Australian Gold Broad Spectrum SPF 8
58443-0074	Australian Gold	Avobenzone, Octisalate, Octocrylene and Oxybenzone
58443-0075	Australian Gold	Avobenzone, Octisalate, Octocrylene and Oxybenzone
58443-0078	Australian Gold	Avobenzone, Octisalate, Octocrylene and Oxybenzone
63868-255	Awaken by Quality Choice Long-Lasting Oil-Free Moisturizer Broad Spectrum SPF 15	Avobenzone, Octisalate, Octocrylene and Oxybenzone
70281-339	BullFrog Land Sport SPF 50 Lip Balm	AVOBENZONE, OCTISALATE, OCTOCRYLENE and OXYBENZONE
36800-360	Long-Lasting Oil-Free Moisturizer	Avobenzone, Octisalate, Octocrylene and Oxybenzone
41250-387	Meijer Elements Long-Lasting Oil-Free	Avobenzone, Octisalate, Octocrylene and Oxybenzone
13630-0046	Suntone	Avobenzone, Octisalate, Octocrylene and Oxybenzone
13630-0045	Sunzen	Avobenzone, Octisalate, Octocrylene and Oxybenzone