Label: THE CURE OIL-FREE- octinoxate, titanium dioxide 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 April 30, 2014

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients                                      Purpose

    Octinoxate 4.8%               

    Titanium Dioxide 6.3%  }                           Sunscreen

  • PURPOSE

    Uses

    Helps prevent sunburn

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Natura Bisse

    Barcelona

    THE CURE

    SHEER 

    OIL-FREE FLUID

    Hidratante detox con color

    Color enhanced moisturizer

    Emulsion Hydratante Teintee

    Mit Farbpitmenten angereicherte

    Feuchtigkeitscreme

    Hidratante detox com cor

    Idratante intenso colorato

    SUNSCREEN

    Broad spectrum SPF 20

    Net Wt. 1.7 oz. e 50 ml

  • WARNINGS

    Warnings

    • 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
  • DOSAGE & ADMINISTRATION

    Directions

    • apply liberally 15 minutes before skin exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: ask a doctor
    • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: 
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sun-glasses
  • INACTIVE INGREDIENT

    Water, Cyclopentasiloxane, Glycerin, Diisopropyl Sebacate, Ethylene/Acrylic Acid Copolymer, Caprylic/Capric Triglyceride, Propylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Salix Alba (Willow) Bark Extract, Tocopheryl Acetate, Glyceryl Linoleate, Arginine, Hydrolyzed Collagen, Bisabolol, Lactic Acid, Sodium Lactate, Serine, Sorbitol, Urea, Glyceryl Linolenate, Niacinamide, Yeast Extract, Aesculus
    Hippocastanum (Horse Chestnut) Seed Extract, Sodium Hyaluronate, Ammonium Glycyrrhizate, Zinc Gluconate, Panthenol, Allantoin, Caffeine, Biotin, Palmitoyl Tripeptide-38, Lepidium Sativum Sprout Extract, Aluminum Hydroxide, Sodium Chloride, Stearic Acid, Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane Crosspolymer, Triethoxycaprylylsilane, Silica Silylate, Stearalkonium Hectorite, Dimethiconol, Disodium EDTA, Palmitamidopropyltrimonium Chloride, Dimethicone Crosspolymer, Propylene Carbonate, Ethylhexylglycerin,
    Pentylene Glycol, Hydroxypropyl Cyclodextrin, Sodium Citrate, Citric Acid, Lecithin, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Fragrance (Parfum), Iron Oxides (CI 77492, CI 77491, CI 77499).

  • OTHER SAFETY INFORMATION

    Other information protect this product from excessive heat and direct sun.

    Questions? 1-800-762-8872

    ESTE PROUCTO SOLO PUEDE VENDERSE EN ESTABLECIMIENTOS AUTORIZADOS POR NATURA BISSE

    THIS PRODUCT CAN BE SOLD ONLY BY AUTHORIZED NATURA BISSE RETAILERS

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    THE CURE OIL-FREE 
    octinoxate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63730-222
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 50 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERYL LINOLEATE (UNII: 4763AXI84L)  
    ARGININE (UNII: 94ZLA3W45F)  
    GELATIN (UNII: 2G86QN327L)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SERINE (UNII: 452VLY9402)  
    SORBITOL (UNII: 506T60A25R)  
    UREA (UNII: 8W8T17847W)  
    GLYCERYL LINOLENATE (UNII: SGB6X4G86K)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    YEAST (UNII: 3NY3SM6B8U)  
    AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CAFFEINE (UNII: 3G6A5W338E)  
    BIOTIN (UNII: 6SO6U10H04)  
    PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
    LEPIDIUM SATIVUM SEED (UNII: WZM06UL78H)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIPHENYL DIMETHICONE (100 CST) (UNII: AG1ANB6B8O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PALMITAMIDOPROPYLTRIMONIUM CHLORIDE (UNII: N2U96D202F)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63730-222-0150 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/21/2014
    Labeler - Natura Bisse International SA (464431576)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natura Bisse International SA464431576manufacture(63730-222)