NDC 63550-852

Sun Defense UVscreen SPF 48

Ensulizole Homosalate Octinoxate Octocrylene Zinc Oxide

Sun Defense UVscreen SPF 48 is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Kamins Dermatologics Inc.. The primary component is Ensulizole; Homosalate; Octinoxate; Octocrylene; Zinc Oxide.

• Product ID: 63550-852_54f7851c-d8e2-45a0-847d-e49cd78c6661
• NDC: 63550-852
• Product Type: Human Otc Drug
• Proprietary Name: Sun Defense UVscreen SPF 48
• Generic Name: Ensulizole Homosalate Octinoxate Octocrylene Zinc Oxide
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2011-09-02
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Kamins Dermatologics Inc.
• Substance Name: ENSULIZOLE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE
• Active Ingredient Strength: 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 63550-852-10

120 mL in 1 BOX (63550-852-10)

• Marketing Start Date: 2011-09-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63550-852-10 [63550085210]

Sun Defense UVscreen SPF 48 CREAM

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-09-02
• Inactivation Date: 2019-10-29

Drug Details

Active Ingredients

Ingredient	Strength
ENSULIZOLE	30 mg/mL

OpenFDA Data

• SPL SET ID: 8326d76e-c1de-498e-abe5-9ecae4e9e6d4
• Manufacturer:
  • Kamins Dermatologics Inc.
• UNII:
  • 4Y5P7MUD51
  • SOI2LOH54Z
  • 5A68WGF6WM
  • 9YQ9DI1W42
  • V06SV4M95S

NDC Crossover Matching brand name "Sun Defense UVscreen SPF 48" or generic name "Ensulizole Homosalate Octinoxate Octocrylene Zinc Oxide"

NDC	Brand Name	Generic Name
63550-852	Sun Defense UVscreen SPF 48	Ensulizole Homosalate Octinoxate Octocrylene Zinc oxide
63550-809	Sunbar SPF 48	Ensulizole Homosalate Octinoxate Octocrylene Zinc oxide