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Laneige (AMOREPACIFIC)

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LOTION 70 mL in 1 TUBE (43419-811-83) Label Information

Complete Laneige Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENTS

    ETHYLHEXYL METHOXYCINNAMATE 7%
    TITANIUM DIOXIDE 5.81%
    ZINC OXIDE 1.96%


  • PURPOSE

    Sunscreen


  • USE

    • helps prevent sunburn

  • 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 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 product is swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water-resistant sunscreen if swimming or sweating
    • children under 6 months of age: Ask a doctor

  • INACTIVE INGREDIENTS

    WATER, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, BUTYLENE GLYCOL, DICAPRYLYL CARBONATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, SORBITAN ISOSTEARATE, DISTEARDIMONIUM HECTORITE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SODIUM CHLORIDE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ALUMINUM HYDROXIDE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, STEARIC ACID, OZOKERITE, CAPRYLYL GLYCOL, SODIUM CITRATE, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, TRIETHOXYCAPRYLYLSILANE, ADENOSINE, MAGNESIUM SULFATE, MANGANESE SULFATE, ZINC SULFATE, FRAGRANCE, TITANIUM DIOXIDE (CI 77891), MICA (CI 77019)


  • OTHER INFORMATION

    • protect the product in this container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

    LANEIGE

    SunScreen
    Triple

    Sunscreen
    SPF 40

    50 mL / 1.6 FL.OZ. e

    Principal Display Panel - 50 mL Tube Carton

  • INGREDIENTS AND APPEARANCE
    LANEIGE SUNSCREEN TRIPLE 
    octinoxate, titanium dioxide, and zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-811
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 70 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 58.1 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 19.6 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ADENOSINE (UNII: K72T3FS567)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    MANGANESE SULFATE (UNII: W00LYS4T26)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43419-811-83 1 in 1 CARTON
    1 50 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 07/05/2013
    Labeler - AMOREPACIFIC (687995683)
    Establishment
    Name Address ID/FEI Business Operations
    AMOREPACIFIC 687995683 MANUFACTURE(43419-811)