Label: ESIKA TRIPLE ACCION MAX BB LIGHT BEIGE- zinc oxide and octinoxate cream
ESIKA TRIPLE ACCION MAX BB DARK BEIGE- zinc oxide and octinoxate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 March 11, 2014

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  • SPL UNCLASSIFIED SECTION

    Información del medicamento

  • ACTIVE INGREDIENT

    Ingredientes activosPropósito
    Zinc Oxide 8.4 %Protector solar
    Ethylhexyl Methoxycinnamate 7.0%Protector solar
  • Uso

    • Ayuda a prevenir quemaduras solares
  • Advertencias

    • Alerta de Cáncer en la piel / envejecimiento de la piel : Pasar tiempo bajo el sol incrementa el riesgo de cáncer y envejecimiento prematuro de la piel. Este producto ha demostrado que unicamente ayuda a prevenir las quemaduras solares pero no previene el cáncer a la piel ni el envejecimiento prematuro de la misma.
    • Sólo para uso externo.

    • No usar en piel dañada o lastimada.

    • Cuando use este producto mantener 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

    • Aplicar generosamente y uniformemente 15 minutos antes de la exposición al sol.
    • Reaplicar por lo menos cada dos horas.
    • Use un protector solar resistente al agua si usted nada o suda.
    • Niños menores a 6 meses de edad: Consulte al médico
  • Otra información

    • Proteja el producto del calor excesivo y del sol directo.
  • Ingredientes inactivos

    Aqua (Water),Dimethicone, PEG-10,Dimethicone, Propylene Glycol, Benzimidazole Diamond Amidoethyl Urea, Carbamoyl Propyl Polymethylsilsesquioxane, Polysilicone-11, PEG/PPG-18/18 Dimethicone, Silica, Phenoxyethanol, Polymethylsilsesquioxane, HDI/TRIMETHYLOL Hexyllactone Crosspolymer, Sodium Chloride, Caprylyl Glycol, Chlorphenesin, Disteardimonium Hectorite, Phenethyl Alcohol, PPG-2,Methyl Ether, Sodium Hyaluronate, Methylisothiazolinone. Puede Contener:CI 77891 (Titanium Dioxide ) , CI 77492 ( Iron Oxides), CI 77491 (Iron Oxides),CI 77499 (Iron Oxides), Triethoxycaprylylsilane.

  • SPL UNCLASSIFIED SECTION

    PR: Dist by Ventura Corp, Ltd., San Juan, Puerto Rico 00926.

  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton - Light Beige

    TRIPLE ACCIÓN
    max

    BB
    CREAM

    CREMA FACIAL
    PERFECCIONADORA
    CON COLOR FPS 30
    6 BENEFICIOS EN 1

    ésika

    30 g e (1 oz.)

    Principal Display Panel - 30 g Tube Carton - Light Beige
  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton - Dark Beige

    TRIPLE ACCIÓN
    max

    BB
    CREAM

    CREMA FACIAL
    PERFECCIONADORA
    CON COLOR FPS 30
    6 BENEFICIOS EN 1

    ésika

    30 g e (1 oz.)

    Principal Display Panel - 30 g Tube Carton - Dark Beige
  • INGREDIENTS AND APPEARANCE
    ESIKA TRIPLE ACCION MAX BB   LIGHT BEIGE
    zinc oxide and octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-999
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.084 g  in 1 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Disteardimonium Hectorite (UNII: X687XDK09L)  
    Phenylethyl Alcohol (UNII: ML9LGA7468)  
    Dimethyl Ether (UNII: AM13FS69BX)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-999-021 in 1 CARTON
    1NDC:13537-999-0130 g in 1 TUBE
    2NDC:13537-999-031 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35203/10/2014
    ESIKA TRIPLE ACCION MAX BB   DARK BEIGE
    zinc oxide and octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-998
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.084 g  in 1 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Disteardimonium Hectorite (UNII: X687XDK09L)  
    Phenylethyl Alcohol (UNII: ML9LGA7468)  
    Dimethyl Ether (UNII: AM13FS69BX)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-998-051 in 1 CARTON
    1NDC:13537-998-0430 g in 1 TUBE
    2NDC:13537-998-061 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35203/10/2014
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-999, 13537-998)
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