Label: CYZONE SUN BY ME FACE SCREEN FPS 50 AMPLIO ESPECTRO- octinoxate, octocrylene, oxybenzone, octisalate, titanium dioxide, and ensulizole cream
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-435-01 - Packager: Ventura Corporation LTD.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated August 16, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Ingredientes activos
- Propósito
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Usos
- Ayuda a prevenir quemaduras solares.
- Si se usa según las indicaciones con otras medidas de protección (ver Instrucciones), disminuye el riesgo de cancer en la piel y el envejecimiento prematuro causados por el sol.
- Advertencias
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Instrucciones
- Aplicar generosamente y uniformemente 15 minutos antes de la exposición al sol.
- Reaplicar:
- Después de 40 minutos de nadar o sudar.
- Inmediatamente despues de secarse con toalla
- Al menos cada 2 horas.
- Niños menores a 6 meses de edad: Consulte al médico
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Medidas de protección solar. Pasar tiempo en el sol incrementa su riesgo de cancer en la piel y envejecimiento prematuro. Para disminuir este riesgo, regularmente use un protector solar con un valor de Amplio Espectro FPS de 15 o mas alto y otras medidas de protección inclueyendo:
- Limitar el tiempo en el sol, especialmente de 10 a.m - 2 p.m.
- Vestir camisas de manga larga, pantalones, sombreros y gafas de sol.
- Otra información
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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.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 60 g Tube Label
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INGREDIENTS AND APPEARANCE
CYZONE SUN BY ME FACE SCREEN FPS 50 AMPLIO ESPECTRO
octinoxate, octocrylene, oxybenzone, octisalate, titanium dioxide, and ensulizole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-435 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 0.468 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:13537-435-01 60 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 09/14/2012 Labeler - Ventura Corporation LTD. (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-435) Establishment Name Address ID/FEI Business Operations Yobel Supply Chain Management S.A. 934116930 MANUFACTURE(13537-435)