KLAVUU WHITE PEARLSATION IDEAL ACTRESS BACKSTAGE CREAM SPF30 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [BEKEIKOREA]

KLAVUU WHITE PEARLSATION IDEAL ACTRESS BACKSTAGE CREAM SPF30 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [BEKEIKOREA]
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NDC 70976-002-01, 70976-002-02
Set ID 8cf1a052-a61b-453c-8e55-090256f0f97d
Category HUMAN OTC DRUG LABEL
Packager Bekeikorea
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Octinoxate 6.70%
    Titanium Dioxide 3.53%
    Octisalate 2.50%

  • 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

    Water, Butylene Glycol, Glycerin, Cyclopentasiloxane, Cyclohexasiloxane, Cetyl Ethylhexanoate, Dicaprylyl Carbonate, Niacinamide, Octyldodecanol, Pentylene Glycol, Pearl Extract, Chlorella Vulgaris Extract, Codium Tomentosum Extract, Ecklonia Cava Extract, Enteromorpha Compressa Extract, Macrocystis Pyrifera (Kelp) Extract, Gelidium Cartilagineum Extract, Laminaria Japonica Extract, Sea Whip Extract, Spirulina Platensis Extract, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Diphenylsiloxy Phenyl Trimethicone, Triceteareth-4 Phosphate, Glycol Stearate, Glyceryl Stearate, PEG-100 Stearate, PEG-2 Stearate, Potassium Cetyl Phosphate, Silica, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Triethanolamine, Aluminum Hydroxide, Stearic Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Ethylhexylglycerin, Adenosine, Triethoxycaprylylsilane, Polysorbate 60, Sorbitan Isostearate, Tocopherol, 1,2-Hexanediol, Caprylyl Glycol, Carbomer, Disodium EDTA, Phenoxyethanol, Methylparaben, Fragrance(Parfum), Mica (CI 77019), Iron Oxides (CI 77492), Iron Oxides (CI 77491)

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    KLAVUU WHITE PEARLSATION IDEAL ACTRESS BACKSTAGE CREAM SPF30 
    octinoxate, titanium dioxide, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70976-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.01 mg  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.06 mg  in 30 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.075 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PEG-2 STEARATE (UNII: 94YQ11Y95F)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICA (UNII: V8A1AW0880)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    SQUALANE (UNII: GW89575KF9)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ADENOSINE (UNII: K72T3FS567)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)  
    CODIUM TOMENTOSUM (UNII: B8B45BRU87)  
    ECKLONIA CAVA (UNII: UXX2N5V39P)  
    ULVA COMPRESSA (UNII: SXZ209FM33)  
    MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
    GELIDIUM CARTILAGINEUM (UNII: 37LBZ0E1UE)  
    LAMINARIA JAPONICA (UNII: WE98HW412B)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    SPIRULINA PLATENSIS (UNII: 9L3TIH1UUE)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70976-002-021 in 1 CARTON09/17/2016
    1NDC:70976-002-0130 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/17/2016
    Labeler - Bekeikorea (689846410)
    Registrant - Bekeikorea (689846410)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(70976-002)

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