Label: LABNO 4SP SAFE NATURAL TONE BB CUSHION- titanium dioxide, zinc oxide powder

  • Category: HUMAN OTC DRUG LABEL

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 July 14, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: TITANIUM DIOXIDE 11.45%, ZINC OXIDE 1.91%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Caprylyl Methicone, Butyloctyl Salicylate, Isotridecyl Isononanoate, Methylpropanediol, Dicaprylyl Carbonate, Caprylic/Capric Triglyceride, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Bis-Hydroxyethoxypropyl Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Iron Oxides(CI 77492), Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Disteardimonium Hectorite, Magnesium Sulfate, Iron Oxides(CI 77491), Glycerin, Triethoxycaprylylsilane, Glyceryl Caprylate, Caprylyl Glycol, Aluminum Hydroxide, Stearic Acid, Iron Oxides(CI 77499), Portulaca Oleracea Extract, Silica Dimethyl Silylate, Ethylhexylglycerin, Methicone, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Pelargonium Graveolens Flower Oil, Butylene Glycol, 1,2-Hexanediol, Salvia Officinalis (Sage) Oil, Pogostemon Cablin Oil, Tocopherol, Hyaluronic Acid, 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 cover blemishes

    - Helps for clear and healthier complexion

    - Provides sun protection

    Directions:

    Apply a proper amount on face using the enclosed puff.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    LABNO 4SP SAFE NATURAL TONE BB CUSHION 
    titanium dioxide, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71497-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.60 g  in 14 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.26 g  in 14 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71497-020-021 in 1 CARTON06/01/2017
    1NDC:71497-020-0114 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 finalpart35206/01/2017
    Labeler - KB Lab Co., Ltd. (694703258)
    Registrant - KB Lab Co., Ltd. (694703258)
    Establishment
    NameAddressID/FEIBusiness Operations
    KB Lab Co., Ltd.694703258relabel(71497-020)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(71497-020)