CYZONE SUN BY ME SUNBLOCK SPF 50- octinoxate, octocrylene, oxybenzone, octisalate, titanium dioxide, and ensulizole cream

Cyzone by

Drug Labeling and Warnings

Cyzone by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation Ltd, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Octinoxate 7.5%	Sunscreen
Octocrylene 7.0%	Sunscreen
Oxybenzone 6.0%	Sunscreen
Octisalate 5.0%	Sunscreen
Titanium Dioxide 4.68%	Sunscreen
Ensulizole 3.0%	Sunscreen

Uses

• Helps prevent sunburn.
• Provides high protection against sunburn.
• Retains SPF after 40 minutes of activity in the water.

Warnings

Skin Cancer / Skin Aging Alert

• Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

• For external use only.

• Do not use on damaged or broken skin.

• When using this product keep out of eyes. Rinse with water to remove.

• Stop use and ask a doctor if rash occurs.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• Children under 6 months of age: Ask a doctor

Other information

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

water, dicaprylyl carbonate, phenethyl benzoate, stearyl dimethicone, dimethicone, arginine, cyclopentasiloxane, cetearyl alcohol, methyl methacrylate crosspolymer, trimethylsiloxysilicate, sorbitan stearate, potassium cetyl phosphate, tocopheryl acetate, phenoxyethanol, silica, methicone, methylparaben, acrylates copolymer, ceteareth-20, propylparaben, xanthan gum, fragrance, butylene glycol, butylparaben, ethylparaben, isobutylparaben, litchi chinensis pericarp extract.

SPL UNCLASSIFIED SECTION

Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 60 g Bottle Label

50 FPS
faceblock

60 g e (2.1 oz.)

sun
by me

cy°zone

INGREDIENTS AND APPEARANCE

CYZONE   SUN BY ME SUNBLOCK SPF 50
octinoxate, octocrylene, oxybenzone, octisalate, titanium dioxide, and ensulizole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-155
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.07 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.06 g  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.0468 g  in 1 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	0.03 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PHENETHYL BENZOATE (UNII: 0C143929GK)
DIMETHICONE (UNII: 92RU3N3Y1O)
ARGININE (UNII: 94ZLA3W45F)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
LITCHI FRUIT (UNII: Y5P61KP51E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-155-01	60 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/24/2012

Labeler - Ventura Corporation Ltd (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE