NDC 13537-435

CYZONE SUN BY ME FACE SCREEN FPS 50 AMPLIO ESPECTRO

Octinoxate, Octocrylene, Oxybenzone, Octisalate, Titanium Dioxide, And Ensulizole

CYZONE SUN BY ME FACE SCREEN FPS 50 AMPLIO ESPECTRO is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Ventura Corporation Ltd.. The primary component is Octinoxate; Octocrylene; Oxybenzone; Octisalate; Titanium Dioxide; Ensulizole.

• Product ID: 13537-435_b82ef368-8abd-47cf-8a63-40fc66b84bf6
• NDC: 13537-435
• Product Type: Human Otc Drug
• Proprietary Name: CYZONE SUN BY ME FACE SCREEN FPS 50 AMPLIO ESPECTRO
• Generic Name: Octinoxate, Octocrylene, Oxybenzone, Octisalate, Titanium Dioxide, And Ensulizole
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2012-09-14
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Ventura Corporation LTD.
• Substance Name: OCTINOXATE; OCTOCRYLENE; OXYBENZONE; OCTISALATE; TITANIUM DIOXIDE; ENSULIZOLE
• Active Ingredient Strength: 0 g/g; g/g; g/g; g/g; g/g; g/g
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 13537-435-01

60 g in 1 TUBE (13537-435-01)

• Marketing Start Date: 2012-09-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 13537-435-01 [13537043501]

CYZONE SUN BY ME FACE SCREEN FPS 50 AMPLIO ESPECTRO CREAM

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-09-14
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
OCTINOXATE	.075 g/g

OpenFDA Data

• SPL SET ID: 63a6e36f-8c13-4a39-999b-b7c0ab8648b2
• Manufacturer:
  • Ventura Corporation LTD.
• UNII:
  • 5A68WGF6WM
  • 15FIX9V2JP
  • 95OOS7VE0Y
  • 4X49Y0596W
  • 4Y5P7MUD51
  • 9YQ9DI1W42

NDC Crossover Matching brand name "CYZONE SUN BY ME FACE SCREEN FPS 50 AMPLIO ESPECTRO" or generic name "Octinoxate, Octocrylene, Oxybenzone, Octisalate, Titanium Dioxide, And Ensulizole"

NDC	Brand Name	Generic Name
13537-155	Cyzone	OCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, TITANIUM DIOXIDE, and ENSULIZOLE
13537-435	CYZONE	Octinoxate, Octocrylene, Oxybenzone, Octisalate, Titanium Dioxide, and Ensulizole