NDC 58443-0136

Australian Gold BROAD SPECTRUM SPF 50

Titanium Dioxide And Zinc Oxide

Australian Gold BROAD SPECTRUM SPF 50 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Prime Enterprises, Inc.. The primary component is Zinc Oxide; Titanium Dioxide.

• Product ID: 58443-0136_7d8a6be4-21b2-b358-e053-2a91aa0a9c45
• NDC: 58443-0136
• Product Type: Human Otc Drug
• Proprietary Name: Australian Gold BROAD SPECTRUM SPF 50
• Generic Name: Titanium Dioxide And Zinc Oxide
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2014-11-18
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Prime Enterprises, Inc.
• Substance Name: ZINC OXIDE; TITANIUM DIOXIDE
• Active Ingredient Strength: 40 mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58443-0136-4

150 mL in 1 BOTTLE (58443-0136-4)

• Marketing Start Date: 2014-11-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0136-4 [58443013604]

Australian Gold BROAD SPECTRUM SPF 50 LOTION

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-11-18

Drug Details

Active Ingredients

Ingredient	Strength
ZINC OXIDE	40.4 mg/mL

OpenFDA Data

• SPL SET ID: 51f5015a-c0db-449a-ae28-bde77eef562e
• Manufacturer:
  • Prime Enterprises, Inc.
• UNII:
  • 15FIX9V2JP
  • SOI2LOH54Z

NDC Crossover Matching brand name "Australian Gold BROAD SPECTRUM SPF 50" or generic name "Titanium Dioxide And Zinc Oxide"

NDC	Brand Name	Generic Name
13630-0014	Australian Gold Broad Spectrum SPF 50	Australian Gold Broad Spectrum SPF 50
13630-0015	Australian Gold Broad Spectrum SPF 50	Australian Gold Broad Spectrum SPF 50
13630-0027	Australian Gold Broad Spectrum SPF 50	Australian Gold Broad Spectrum SPF 50
13630-0018	Australian Gold Broad Spectrum SPF 50	Australian Gold Broad Spectrum SPF 50
13630-0023	Australian Gold Broad Spectrum SPF 50	Australian Gold Broad Spectrum SPF 50
13630-0025	Australian Gold Broad Spectrum SPF 50	Australian Gold Broad Spectrum SPF 50
13630-0063	Australian Gold Broad Spectrum SPF 50	Australian Gold Broad Spectrum SPF 50
13630-0026	Australian Gold Broad Spectrum SPF 50	Australian Gold Broad Spectrum SPF 50
58443-0079	Australian Gold BROAD SPECTRUM SPF 50	Australian Gold BROAD SPECTRUM SPF 50
58443-0042	Australian Gold Broad Spectrum SPF 50	Australian Gold Broad Spectrum SPF 50
58443-0073	Australian Gold BROAD SPECTRUM SPF 50	Australian Gold BROAD SPECTRUM SPF 50
58443-0136	Australian Gold BROAD SPECTRUM SPF 50	Australian Gold BROAD SPECTRUM SPF 50
58443-0020	Australian Gold Broad Spectrum SPF 50	Australian Gold Broad Spectrum SPF 50
58443-0350	Australian Gold BROAD SPECTRUM SPF 50	Australian Gold BROAD SPECTRUM SPF 50
13630-0168	Australian Gold Broad Spectrum SPF 50	Australian Gold Broad Spectrum SPF 50
0316-0300	BIOJUVE Microbiome-Safe Sheer Finish SPF 50 Sunscreen	Titanium Dioxide and Zinc Oxide
0316-2035	Blue Lizard Baby	Titanium Dioxide and Zinc Oxide
0316-2036	Blue Lizard Baby SPF 50 Sunscreen	Titanium Dioxide and Zinc Oxide
0316-2046	Blue Lizard Sensitive SPF 50 Sunscreen	Titanium Dioxide and Zinc Oxide
0316-2045	Blue Lizard Sensitive Sunscreen	Titanium Dioxide and Zinc Oxide
0316-2057	Blue Lizard Sheer Face SPF 50 Sunscreen	Titanium Dioxide and Zinc Oxide
0187-2224	CeraVe	titanium dioxide and zinc oxide
11559-047	DOUBLE WEAR CUSHION BB ALL DAY WEAR COMPACT BROAD SPECTRUM SPF 50	TITANIUM DIOXIDE and ZINC OXIDE
0023-5675	Essential Defense Mineral Shield Broad Spectrum SPF 32 TINTED Sunscreen	Titanium Dioxide and Zinc Oxide
0023-5703	Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen	Titanium Dioxide and Zinc oxide
13537-237	LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15	Titanium Dioxide and Zinc Oxide
10812-007	Neutrogena Healthy Defense SPF50	Titanium Dioxide and Zinc Oxide
10812-430	Neutrogena Pure and Free	Titanium Dioxide and Zinc Oxide
10812-324	Neutrogena Pure and Free Baby	Titanium Dioxide and Zinc Oxide
10812-420	Neutrogena Pure and Free Baby Faces	Titanium Dioxide and Zinc Oxide
10812-443	Neutrogena Pure and Free Baby Sunscreen	Titanium Dioxide and Zinc Oxide
10812-434	Neutrogena Sensitive Skin	Titanium Dioxide and Zinc Oxide
0316-0263	PanOxyl Oil Control Moisturizer	Titanium Dioxide and Zinc Oxide
11559-050	PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45	TITANIUM DIOXIDE and ZINC OXIDE
0363-9926	Walgreens Baby SPF50	Titanium Dioxide and Zinc Oxide
0363-9936	Walgreens Baby SPF50	Titanium Dioxide and Zinc Oxide