Label: CYZONE- octinoxate and oxybenzone 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 May 26, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Octinoxate 5.5 %sunscreen
    OXYBENZONE 4.00%sunscreen
  • Uses

    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
    • Provides minimal protection against sunburn
  • Warnings

    For external use only

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash or irritation develops and lasts

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Directions

    • Apply liberally before sun exposure and as needed
  • Other information

    • Sun alert: Limiting sun exposure, waring protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.
  • Inactive ingredients

    AQUA (WATER), PROPYLENE GLYCOL, CYCLOHEXASILOXANE, CYCLOPENTASILOXANE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, GLYCERYL STEARATE SE, C12-15 ALKYL BENZOATE, CETEARYL ALCOHOL, CETYL ALCOHOL, GLYCERIN, PANTHENOL, C12-14 PARETH-12, PHENOXYETHANOL, ISOPROPYL PALMITATE, GLYCERYL STEARATE, METHYL METHACRYLATE CROSSPOLYMER, DIMETHICONE, METHYLPARABEN, PROPYLPARABEN, PANAX GINSENG ROOT EXTRACT, XANTHAN GUM, CETEARETH-20, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DIMETHICONE CROSSPOLYMER, PARFUM (FRAGRANCE), SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, DIMETHICONOL, ISOHEXADECANE, TILIA CORDATA WOOD EXTRACT, TETRASODIUM EDTA, HYDROLYZED WHEAT PROTEIN, MANNITOL, BUTYLPARABEN, ETHYLPARABEN, TRIETHANOLAMINE, AESCULUS HIPPOCASTANUM SEED EXTRACT (AESCULUS HIPPOCASTANUM (HORSE CHESTNUT) SEED EXTRACT), POLYSORBATE 80, ISOBUTYLPARABEN, GLYCOGEN, PEG-60 ACEITE DE RICINO HIDROGENADO, FAEX EXTRACT (YEAST EXTRACT), AVENA SATIVA KERNEL EXTRACT (AVENA SATIVA (OAT) KERNEL EXTRACT), TRITICUM VULGARE GERM EXTRACT (TRITICUM VULGARE (WHEAT) GERM EXTRACT), TRITICUM VULGARE GERM OIL (TRITICUM VULGARE (WHEAT) GERM OIL), ACTINIDIA CHINENSIS FRUIT EXTRACT (ACTINIDIA CHINENSIS (KIWI) FRUIT EXTRACT), HELIANTHUS ANNUUS SEED OIL (HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL), CALCIUM PANTOTHENATE, CUCUMIS SATIVUS FRUIT EXTRACT (CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT), BIOTINUM (BIOTIN)

  • PRINCIPAL DISPLAY PANEL - 60 g Bottle

    xpress
    your face

    crema facial

    hidratante
    multibeneficios
    FPS 10

    cy°zone

    60 g e (2.1 oz.)

    PRINCIPAL DISPLAY PANEL - 60 g Bottle
  • INGREDIENTS AND APPEARANCE
    CYZONE   EXPRESS YOUR FACE
    octinoxate and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-356
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.055 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    TILIA CORDATA WOOD (UNII: 674MYE89IE)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    MANNITOL (UNII: 3OWL53L36A)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    GLYCOGEN (UNII: 309GSC92U1)  
    YEAST (UNII: 3NY3SM6B8U)  
    OAT (UNII: Z6J799EAJK)  
    WHEAT GERM (UNII: YR3G369F5A)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    CUCUMBER (UNII: YY7C30VXJT)  
    BIOTIN (UNII: 6SO6U10H04)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-356-0160 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35205/27/2011
    Labeler - Ventura Corporation (San Juan, P.R) (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE
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