NDC 58443-0032

Australian Gold Broad Spectrum SPF 45

Avobenzone,homosalate, Octisalate, And Octocrylene

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.

• Product ID: 58443-0032_7d7844a0-ec14-0729-e053-2991aa0a0afc
• NDC: 58443-0032
• Product Type: Human Otc Drug
• Proprietary Name: Australian Gold Broad Spectrum SPF 45
• Generic Name: Avobenzone,homosalate, Octisalate, And Octocrylene
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-01-25
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Prime Enterprises, Inc.
• Substance Name: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
• Active Ingredient Strength: 29 mg/mL; mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58443-0032-3

88 mL in 1 TUBE (58443-0032-3)

• Marketing Start Date: 2013-01-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0032-3 [58443003203]

Australian Gold Broad Spectrum SPF 45 LOTION

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-01-25

Drug Details

Active Ingredients

Ingredient	Strength
AVOBENZONE	28.9 mg/mL

OpenFDA Data

• SPL SET ID: de4282ab-8530-4ad0-b459-8e573e89fd8f
• Manufacturer:
  • Prime Enterprises, Inc.
• UNII:
  • G63QQF2NOX
  • 4X49Y0596W
  • 5A68WGF6WM
  • V06SV4M95S
• UPC Code:
  • 0054402700587

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

NDC	Brand Name	Generic Name
58443-0033	Australian Gold Broad Spectrum SPF 45	Australian Gold Broad Spectrum SPF 45
58443-0032	Australian Gold	Avobenzone,Homosalate, Octisalate, and Octocrylene