NDC 58443-0083

Australian Gold Hello Kitty BROAD SPECTRUM SPF 45

Titanium Dioxide And Zinc Oxide

Australian Gold Hello Kitty 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 Titanium Dioxide; Zinc Oxide.

• Product ID: 58443-0083_7d7bb750-0159-c60e-e053-2991aa0ad671
• NDC: 58443-0083
• Product Type: Human Otc Drug
• Proprietary Name: Australian Gold Hello Kitty BROAD SPECTRUM SPF 45
• Generic Name: Titanium Dioxide And Zinc Oxide
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-12-23
• 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: 45 mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58443-0083-3

88 mL in 1 BOTTLE (58443-0083-3)

• Marketing Start Date: 2013-12-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0083-3 [58443008303]

Australian Gold Hello Kitty BROAD SPECTRUM SPF 45 LOTION

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-12-23

Drug Details

Active Ingredients

Ingredient	Strength
TITANIUM DIOXIDE	45.45 mg/mL

OpenFDA Data

• SPL SET ID: 38628d1f-22eb-41a2-b94f-7d9601189f07
• Manufacturer:
  • Prime Enterprises, Inc.
• UNII:
  • 15FIX9V2JP
  • SOI2LOH54Z
• UPC Code:
  • 0054402700938

NDC Crossover Matching brand name "Australian Gold Hello Kitty BROAD SPECTRUM SPF 45" or generic name "Titanium Dioxide And Zinc Oxide"

NDC	Brand Name	Generic Name
58443-0083	Australian Gold Hello Kitty BROAD SPECTRUM SPF 45	Australian Gold Hello Kitty BROAD SPECTRUM SPF 45
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