CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (LIGHT 1) - BEIGE (OCTINOXATE) POWDER CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (LIGHT 2) - BEIGE (OCTI

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  • CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (LIGHT 1) - BEIGE (OCTINOXATE) POWDER CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (LIGHT 2) - BEIGE (OCTI

CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (LIGHT 1) - BEIGE (OCTINOXATE) POWDER CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (LIGHT 2) - BEIGE (OCTI
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NDC 13537-482-01, 13537-483-01, 13537-484-01, 13537-485-01, 13537-486-01, 13537-487-01, 13537-488-01
Set ID fee48a02-cfbe-46da-b023-e8236b844e65
Category HUMAN OTC DRUG LABEL
Packager Ventura Corporation LTD
Generic Name
Product Class
Product Number
Application Number PART352
View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    OCTINOXATE 5.00%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
  • 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 at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating.
    • 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

    MICA, TALC, ZINC STEARATE, BORON NITRIDE, DIMETHICONE, OCTYLDODECANOL, TRIMETHYLSILOXYSILICATE, METHYL METHACRYLATE CROSSPOLYMER, PERFLUOROOCTYL TRIETHOXYSILANE, TOCOPHERYL ACETATE, MAGNESIUM MYRISTATE, PHENOXYETHANOL, CAPRYLYL GLYCOL, FRAGRANCE, CHLORPHENESIN.

    MAY CONTAIN:
    TITANIUM DIOXIDE, IRON OXIDES.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (LIGHT 1) - BEIGE

    cy°zone

    STUDIO
    LOOK
    cy°zone

    POLVOS COMPACTOS DE ALTA
    COBERTURA CON FPS 20

    Net Wt. 0.24 oz. (7g.)

    PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (LIGHT 1) - BEIGE
  • PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (LIGHT 2) - BEIGE

    cy°zone

    STUDIO
    LOOK
    cy°zone

    POLVOS COMPACTOS DE ALTA
    COBERTURA CON FPS 20

    Net Wt. 0.24 oz. (7g.)

    PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (LIGHT 2) - BEIGE
  • PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (MEDIUM 1) - BEIGE

    cy°zone

    STUDIO
    LOOK
    cy°zone

    POLVOS COMPACTOS DE ALTA
    COBERTURA CON FPS 20

    Net Wt. 0.24 oz. (7g.)

    PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (MEDIUM 1) - BEIGE
  • PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (MEDIUM 2) - BEIGE

    cy°zone

    STUDIO
    LOOK
    cy°zone

    POLVOS COMPACTOS DE ALTA
    COBERTURA CON FPS 20

    Net Wt. 0.24 oz. (7g.)

    PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (MEDIUM 2) - BEIGE
  • PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (MEDIUM 3) - BEIGE

    cy°zone

    STUDIO
    LOOK
    cy°zone

    POLVOS COMPACTOS DE ALTA
    COBERTURA CON FPS 20

    Net Wt. 0.24 oz. (7g.)

    PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (MEDIUM 3) - BEIGE
  • PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (MEDIUM 4) - BROWN

    cy°zone

    STUDIO
    LOOK
    cy°zone

    POLVOS COMPACTOS DE ALTA
    COBERTURA CON FPS 20

    Net Wt. 0.24 oz. (7g.)

    PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (MEDIUM 4) - BROWN
  • PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (OBSCURE 1) - BROWN

    cy°zone

    STUDIO
    LOOK
    cy°zone

    POLVOS COMPACTOS DE ALTA
    COBERTURA CON FPS 20

    Net Wt. 0.24 oz. (7g.)

    PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (OBSCURE 1) - BROWN
  • INGREDIENTS AND APPEARANCE
    CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20   (LIGHT 1) - BEIGE
    octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-482
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-482-011 in 1 BOX
    17 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/24/2015
    CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20   (LIGHT 2) - BEIGE
    octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-483
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-483-011 in 1 BOX
    17 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/24/2015
    CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20   (MEDIUM 1) - BEIGE
    octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-484
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-484-011 in 1 BOX
    17 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/24/2015
    CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20   (MEDIUM 2) - BEIGE
    octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-485
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-485-011 in 1 BOX
    17 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/24/2015
    CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20   (MEDIUM 3) - BEIGE
    octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-486
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-486-011 in 1 BOX
    17 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/24/2015
    CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20   (MEDIUM 4) - BROWN
    octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-487
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-487-011 in 1 BOX
    17 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/24/2015
    CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20   (OBSCURE 1) - BROWN
    octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-488
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-488-011 in 1 BOX
    17 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/24/2015
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-482, 13537-483, 13537-484, 13537-485, 13537-486, 13537-487, 13537-488)
View All Sections

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