CYZONE  SUN BY ME FACE SCREEN FPS 50 AMPLIO ESPECTRO- octinoxate, octocrylene, oxybenzone, octisalate, titanium dioxide, and ensulizole cream 
Ventura Corporation LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CYZONE SUN BY ME FACE SCREEN FPS 50 AMPLIO ESPECTRO

Información del medicamento

Ingredientes activos

OCTINOXATE 7.5%, OCTOCRYLENE 7.0%, OXYBENZONE 6.0%, OCTISALATE 5.0%, TITANIUM DIOXIDE 4.68%, ENSULIZOLE 3.0%

Propósito

Protector solar

Usos

Advertencias

  • Sólo para uso externo.
  • No usar en piel dañada o lastimada.

  • Cuando use este producto mantenerlo alejado de los ojos. Enjuagar con agua para eliminar.

  • Detenga su uso y consulte al doctor si sucede enrojecimiento.

  • Mantener fuera del alcance de los niños. Si es ingerido obtener ayuda médica o contactar al centro de Control de Envenenamiento inmediatamente

Instrucciones

Otra información

Ingredientes inactivos

AQUA (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, PARFUM (FRAGRANCE), BUTYLENE GLYCOL, BUTYLPARABEN, ETHYLPARABEN, ISOBUTYLPARABEN, LITCHI CHINENSIS PERICARP EXTRACT.

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

PRINCIPAL DISPLAY PANEL - 60 g Tube Label

50 FPS
amplio espectro
face screen

Protector solar facial
FPS 50 de uso diario
Resistente al agua
(40 minutos)

60 g e (2.1 oz.)

sun
by me

cy°zone

PRINCIPAL DISPLAY PANEL - 60 g Tube Label
CYZONE   SUN BY ME FACE SCREEN FPS 50 AMPLIO ESPECTRO
octinoxate, octocrylene, oxybenzone, octisalate, titanium dioxide, and ensulizole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-435
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.07 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.06 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.468 g  in 1 g
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole0.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-435-0160 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/14/2012
Labeler - Ventura Corporation LTD. (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-435)
Establishment
NameAddressID/FEIBusiness Operations
Yobel Supply Chain Management S.A.934116930MANUFACTURE(13537-435)

Revised: 8/2012
Document Id: b82ef368-8abd-47cf-8a63-40fc66b84bf6
Set id: 63a6e36f-8c13-4a39-999b-b7c0ab8648b2
Version: 1
Effective Time: 20120816
 
Ventura Corporation LTD.