NDC 51514-0235

Babyganics SPF 50

Octinoxate, Octisalate, And Zinc

Babyganics SPF 50 is a Topical Spray in the Human Otc Drug category. It is labeled and distributed by Autumn Harp, Inc.. The primary component is Zinc Oxide; Octinoxate; Octisalate.

• Product ID: 51514-0235_87630dc9-73ce-4ec1-bb04-d08159ec6aba
• NDC: 51514-0235
• Product Type: Human Otc Drug
• Proprietary Name: Babyganics SPF 50
• Generic Name: Octinoxate, Octisalate, And Zinc
• Dosage Form: Spray
• Route of Administration: TOPICAL
• Marketing Start Date: 2012-02-23
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Autumn Harp, Inc.
• Substance Name: ZINC OXIDE; OCTINOXATE; OCTISALATE
• Active Ingredient Strength: 112 mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 51514-0235-1

177 mL in 1 BOTTLE (51514-0235-1)

• Marketing Start Date: 2013-06-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51514-0235-1 [51514023501]

Babyganics SPF 50 SPRAY

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-06-21
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ZINC OXIDE	112 mg/mL

OpenFDA Data

• SPL SET ID: f40a8efa-2cbe-4e99-aba3-66eb59b70332
• Manufacturer:
  • Autumn Harp, Inc.
• UNII:
  • SOI2LOH54Z
  • 4X49Y0596W
  • 4Y5P7MUD51