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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 27, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    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

    PRINCIPAL DISPLAY PANEL - 60 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    CYZONE   SUN BY ME SUNBLOCK SPF 50
    octinoxate, octocrylene, oxybenzone, octisalate, titanium dioxide, and ensulizole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-155
    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 DIOXIDE0.0468 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:13537-155-0160 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35201/24/2012
    Labeler - Ventura Corporation Ltd (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE
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