NDC 58443-0081

Australian Gold BROAD SPECTRUM SPF30

Tianium Dioxide And Zinc Oxide

Australian Gold BROAD SPECTRUM SPF30 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Prime Enterprises, Inc.. The primary component is Titanium Dioxide; Zinc Oxide.

• Product ID: 58443-0081_7d7b9cc1-c477-5d2b-e053-2991aa0a7394
• NDC: 58443-0081
• Product Type: Human Otc Drug
• Proprietary Name: Australian Gold BROAD SPECTRUM SPF30
• Generic Name: Tianium Dioxide And Zinc Oxide
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-12-12
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Prime Enterprises, Inc.
• Substance Name: TITANIUM DIOXIDE; ZINC OXIDE
• Active Ingredient Strength: 30 mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58443-0081-4

150 mL in 1 BOTTLE (58443-0081-4)

• Marketing Start Date: 2013-12-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0081-4 [58443008104]

Australian Gold BROAD SPECTRUM SPF30 LOTION

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-12-12

Drug Details

Active Ingredients

Ingredient	Strength
TITANIUM DIOXIDE	29.8 mg/mL

OpenFDA Data

• SPL SET ID: 2417124e-d934-40f7-9a87-578dff00ed34
• Manufacturer:
  • Prime Enterprises, Inc.
• UNII:
  • 15FIX9V2JP
  • SOI2LOH54Z