NDC 58443-0033

Australian Gold Broad Spectrum SPF 45

Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone

Australian Gold Broad Spectrum SPF 45 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Prime Enterprises, Inc.. The primary component is Avobenzone; Homosalate; Octisalate; Octocrylene; Oxybenzone.

• Product ID: 58443-0033_7d7844a0-ec15-0729-e053-2991aa0a0afc
• NDC: 58443-0033
• Product Type: Human Otc Drug
• Proprietary Name: Australian Gold Broad Spectrum SPF 45
• Generic Name: Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-02-04
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Prime Enterprises, Inc.
• Substance Name: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
• Active Ingredient Strength: 31 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58443-0033-3

88 mL in 1 TUBE (58443-0033-3)

• Marketing Start Date: 2013-02-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0033-3 [58443003303]

Australian Gold Broad Spectrum SPF 45 LOTION

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-02-04

Drug Details

Active Ingredients

Ingredient	Strength
AVOBENZONE	30.6 mg/mL

OpenFDA Data

• SPL SET ID: 82f33116-add9-4a3c-9596-1850c403abb7
• Manufacturer:
  • Prime Enterprises, Inc.
• UNII:
  • G63QQF2NOX
  • 95OOS7VE0Y
  • 4X49Y0596W
  • 5A68WGF6WM
  • V06SV4M95S
• UPC Code:
  • 0054402700488

NDC Crossover Matching brand name "Australian Gold Broad Spectrum SPF 45" or generic name "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone"

NDC	Brand Name	Generic Name
58443-0032	Australian Gold Broad Spectrum SPF 45	Australian Gold Broad Spectrum SPF 45
58443-0033	Australian Gold Broad Spectrum SPF 45	Australian Gold Broad Spectrum SPF 45
0187-5475	Ambi Even and Clear Daily Moisturizer	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-425	Neurogena Healthy Defense Moisturizer	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-050	Neutrogena Age Shield Face	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-427	Neutrogena Age Shield Face Oil Free	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-326	Neutrogena Ageless Intensive Anti-Wrinkle	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-445	Neutrogena Beach Defense	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-416	Neutrogena Beach Defense Water Plus Sun Protection	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-418	Neutrogena Beach Defense Water Plus Sun Protection	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-130	Neutrogena Clinical Lifting Wrinkle Treatment System	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-173	Neutrogena Clinical Lifting Wrinkle Treatment System	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-461	Neutrogena Cooldry Sport Sunscreen Broad Spectrum SPF 50	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-448	Neutrogena CoolDry Sport with Micromesh	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-449	Neutrogena CoolDry Sport with Micromesh	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-452	Neutrogena CoolDry Sport with Micromesh	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-460	Neutrogena CoolDry Sport with Micromesh Sunscreen Broad Spectrum SPF50 Plus	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-248	Neutrogena Day Activating	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-367	Neutrogena Men Sensitive Skin Oil Free Moisture	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-043	Neutrogena Spectrum Plus Advanced	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-432	Neutrogena Spectrum Plus Advanced	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-042	Neutrogena Spectrum Plus Face Advanced Oil Free	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-433	Neutrogena Sport Face Oil Free	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-366	Neutrogena Ultra Sheer Dry Touch	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-423	Neutrogena Ultra Sheer Dry Touch	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-283	Neutrogena Ultra Sheer Dry Touch Sunscreen	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
10812-188	Neutrogena Visibly Even Daily Moisturizer	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone