LABNO 4SP SAFE TONE UP SUN (TITANIUM DIOXIDE) CREAM [KB LAB CO., LTD.]

LABNO 4SP SAFE TONE UP SUN (TITANIUM DIOXIDE) CREAM [KB LAB CO., LTD.]
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NDC 71497-010-01, 71497-010-02
Set ID 326264eb-af49-4c8c-ba5a-b4d07a5ab50c
Category HUMAN OTC DRUG LABEL
Packager KB Lab Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients: Titanium Dioxide 2.52%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Dibutyl Adipate, C12-15 Alkyl Benzoate, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Butyloctyl Salicylate, Polysilicone-15, 1,2-Hexanediol, Ethylhexyl Triazone, Behenyl Alcohol, Arachidyl Alcohol, Cetearyl Alcohol, Butylene Glycol, Silica, Glyceryl Stearate, Cetyl Alcohol, Arachidyl Glucoside, Propanediol, Octyldodecanol, Sodium Stearoyl Glutamate, Polyglyceryl-2 Caprate, Polyacrylate Crosspolymer-6, Saccharide Hydrolysate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sucrose Stearate, Xanthan Gum, Simmondsia Chinensis (Jojoba) Seed Oil, Stearic Acid, Alumina, Ethylhexylglycerin, Glyceryl Caprylate, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Echium Plantagineum Seed Oil, Pelargonium Graveolens Flower Oil, Portulaca Oleracea Extract, Centella Asiatica Extract, Squalane, Houttuynia Cordata Extract, Curcuma Longa (Turmeric) Root Extract, Salvia Hispanica Seed Extract, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, T-Butyl Alcohol, Salvia Officinalis (Sage) Oil, Pogostemon Cablin Oil, Tocopherol, Camellia Japonica Flower Extract, Prunus Serrulata Flower Extract, Acer Saccharum (Sugar Maple) Extract, Rose Extract, Soluble Collagen, Arginine, Ceramide Np, Elastin

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings: For external use only Avoid contact with eyes. Rinse with water to remove. Discontinue use and consult a doctor if signs of irritation or rashes appear. Replace the cap after use.

    Keep Out of Reach of Children: If swallowed, get medical help or contact a Poison Control Center immediately.

  • DESCRIPTION

    Uses:

    - Helps to prevent sunburn

    - Helps to provide sun protection

    - Higher SPF provides strong sun protection

    Directions:

    - Apply generously as needed.

    - Reapply as needed or after towel drying, swimming or sweating.

    - Children under 6 months of age: Ask a doctor.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    LABNO 4SP SAFE TONE UP SUN 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71497-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.26 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Dibutyl Adipate (UNII: F4K100DXP3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71497-010-021 in 1 CARTON06/01/2017
    1NDC:71497-010-0150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2017
    Labeler - KB Lab Co., Ltd. (694703258)
    Registrant - KB Lab Co., Ltd. (694703258)
    Establishment
    NameAddressID/FEIBusiness Operations
    KB Lab Co., Ltd.694703258relabel(71497-010)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(71497-010)

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