Label: KLAVUU BLUEPEARLSATION HIGH COVERAGE MARINE COLLAGEN AQUA CUSHION 23- titanium dioxide, octinoxate, zinc oxide, octisalate cream

  • NDC Code(s): 70976-004-01, 70976-004-02
  • Packager: Bekeikorea
  • 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 December 13, 2016

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  • ACTIVE INGREDIENT

    Titanium Dioxide 8.83%
    Octinoxate 7.00%
    Zinc Oxide 4.90%
    Octisalate 4.50%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps prevent sunburn

  • DOSAGE & ADMINISTRATION

    Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

    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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

    Ask a doctor to use for children under 6 months

  • 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 using and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    Cyclopentasiloxane, Chondrus Crispus Extract, Plankton Extract, Sea Whip Extract, Jania Rubens Extract, Phenyl Trimethicone, Glycerin, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, Trimethylsiloxysilicate, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Methyl Trimethicone, Niacinamide, Pentylene Glycol, Iron Oxides (CI 77492), Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer, Magnesium Sulfate, Phenoxyethanol, Disteardimonium Hectorite, Dimethicone, Caprylyl Methicone, Synthetic Fluorphlogopite, Cetyl PEG/PPG-10/1 Dimethicone, Aluminum Hydroxide, Stearic Acid, Iron Oxides (CI 77491), Dimethicone/Vinyl Dimethicone Crosspolymer, Fragrance(Parfum), Triethoxycaprylylsilane, Iron Oxides (CI 77499), Ethylhexylglycerin, Adenosine, Disodium EDTA, Water, Hydrolyzed Collagen, Hydrolyzed Pearl, Dimethicone Crosspolymer, Sodium Hyaluronate, Hydrogenated Castor Oil Isostearate, 1,2-Hexanediol, Polyglutamic Acid

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    KLAVUU BLUEPEARLSATION HIGH COVERAGE MARINE COLLAGEN AQUA CUSHION 23 
    titanium dioxide, octinoxate, zinc oxide, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70976-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.06 g  in 12 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.84 g  in 12 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.59 g  in 12 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.54 g  in 12 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ADENOSINE (UNII: K72T3FS567)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70976-004-021 in 1 CARTON12/12/2016
    1NDC:70976-004-0112 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/12/2016
    Labeler - Bekeikorea (689846410)
    Registrant - Bekeikorea (689846410)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(70976-004)