NDC 58443-0218

Australian Gold Baby SPF 50 Sunscreen

Homosalate, Octinoxate, Octisalate And Titanium Dioxide

Australian Gold Baby SPF 50 Sunscreen 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; Homosalate; Octisalate; Octinoxate.

• Product ID: 58443-0218_280dccf1-955b-3e9d-e054-00144ff88e88
• NDC: 58443-0218
• Product Type: Human Otc Drug
• Proprietary Name: Australian Gold Baby SPF 50 Sunscreen
• Generic Name: Homosalate, Octinoxate, Octisalate And Titanium Dioxide
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2015-11-02
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Prime Enterprises Inc.
• Substance Name: TITANIUM DIOXIDE; HOMOSALATE; OCTISALATE; OCTINOXATE
• Active Ingredient Strength: 26 mg/mL; mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58443-0218-4

237 mL in 1 BOTTLE (58443-0218-4)

• Marketing Start Date: 2015-11-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0218-4 [58443021804]

Australian Gold Baby SPF 50 Sunscreen LOTION

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-11-02

Drug Details

Active Ingredients

Ingredient	Strength
TITANIUM DIOXIDE	25.5 mg/mL

OpenFDA Data

• SPL SET ID: 280dc4d4-7748-3c13-e054-00144ff8d46c
• Manufacturer:
  • Prime Enterprises Inc.
• UNII:
  • 15FIX9V2JP
  • 4X49Y0596W
  • V06SV4M95S
  • 4Y5P7MUD51

NDC Crossover Matching brand name "Australian Gold Baby SPF 50 Sunscreen" or generic name "Homosalate, Octinoxate, Octisalate And Titanium Dioxide"

NDC	Brand Name	Generic Name
58443-0200	Australian Gold	homosalate, octinoxate, octisalate and titanium dioxide
58443-0218	Australian Gold	homosalate, octinoxate, octisalate and titanium dioxide
58232-0512	Aveeno	Homosalate, Octinoxate, Octisalate and Titanium Dioxide