NDC 71638-0013

Dermafirm Sunblock

Ethylhexyl Methoxycinnamate, Zinc Oxide, Ethylhexyl Salicylate, Titanium Dioxide, Isoamyl P-methoxycinnamate

Dermafirm Sunblock is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Dermafirm Inc.. The primary component is Zinc Oxide; Octisalate; Titanium Dioxide; Octinoxate; Amiloxate.

• Product ID: 71638-0013_6d3e1ced-e9ad-09be-e053-2991aa0a64e5
• NDC: 71638-0013
• Product Type: Human Otc Drug
• Proprietary Name: Dermafirm Sunblock
• Generic Name: Ethylhexyl Methoxycinnamate, Zinc Oxide, Ethylhexyl Salicylate, Titanium Dioxide, Isoamyl P-methoxycinnamate
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-04-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Dermafirm INC.
• Substance Name: ZINC OXIDE; OCTISALATE; TITANIUM DIOXIDE; OCTINOXATE; AMILOXATE
• Active Ingredient Strength: 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 71638-0013-1

50 mL in 1 TUBE (71638-0013-1)

• Marketing Start Date: 2018-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71638-0013-1 [71638001301]

Dermafirm Sunblock CREAM

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-04-01

Drug Details

Active Ingredients

Ingredient	Strength
ZINC OXIDE	4.9 g/100mL

OpenFDA Data

• SPL SET ID: 6d3e1ced-e9ac-09be-e053-2991aa0a64e5
• Manufacturer:
  • Dermafirm INC.
• UNII:
  • 15FIX9V2JP
  • SOI2LOH54Z
  • 4X49Y0596W
  • 4Y5P7MUD51
  • 376KTP06K8
• UPC Code:
  • 8809310531554