NDC 58443-0177

Australian Gold SPF 15 Sheer Coverage Sunscreen

Avobenzone, Octocrylene, And Octisalate

Australian Gold SPF 15 Sheer Coverage Sunscreen 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; Octisalate.

• Product ID: 58443-0177_2b70d706-35b1-29da-e054-00144ff8d46c
• NDC: 58443-0177
• Product Type: Human Otc Drug
• Proprietary Name: Australian Gold SPF 15 Sheer Coverage Sunscreen
• Generic Name: Avobenzone, Octocrylene, And Octisalate
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2014-02-28
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Prime Enterprises Inc.
• Substance Name: AVOBENZONE; OCTOCRYLENE; OCTISALATE
• Active Ingredient Strength: 19 mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58443-0177-4

177 mL in 1 TUBE (58443-0177-4)

• Marketing Start Date: 2014-02-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0177-4 [58443017704]

Australian Gold SPF 15 Sheer Coverage Sunscreen LOTION

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-02-28

Drug Details

Active Ingredients

Ingredient	Strength
AVOBENZONE	18.8 mg/mL

OpenFDA Data

• SPL SET ID: 2b70d706-35b0-29da-e054-00144ff8d46c
• Manufacturer:
  • Prime Enterprises Inc.
• UNII:
  • G63QQF2NOX
  • 4X49Y0596W
  • 5A68WGF6WM

NDC Crossover Matching brand name "Australian Gold SPF 15 Sheer Coverage Sunscreen" or generic name "Avobenzone, Octocrylene, And Octisalate"

NDC	Brand Name	Generic Name
58443-0177	Australian Gold	Avobenzone, octocrylene, and octisalate
58443-0198	The Good Stuff	Avobenzone, octocrylene, and octisalate