Label: SIERO LABBRA SATIN PINK TASSEL- dimethicone gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 29, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: DIMETHICONE 28.0%

  • INACTIVE INGREDIENT

    Inactive ingredients: HYDROGENATED POLYISOBUTENE, SILICA, KAOLIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DIISOSTEARYL MALATE, DIMETHICONE CROSSPOLYMER, BIS-DIGLYCERYL POLYACYLADIPATE-2, POLYETHYLENE, TITANIUM DIOXIDE, RED 7 LAKE(CI 15850:1), RED 6 (CI 15850), CI 45410, PHENOXYETHANOL, CAPRYLYL GLYCOL, YELLOW 5 LAKE(CI 19140), GLYCERYL CAPRYLATE, TOCOPHERYL ACETATE, FRAGRANCE, BLUE 1 LAKE (CI 42090), TOCOPHEROL, ROSA CANINA FRUIT OIL, EUCALYPTUS GLOBULUS LEAF OIL, GLYCERIN, WATER, RHODODENDRON FERRUGINEUM EXTRACT

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: - There may by cracks or cakiness due to the nature of product formulations, but there is no problem with the product. Please do not worry about it. - Keep away from direct sunlight and high temperature. - For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses: It gives bright and vivid color for smooth, matte texture lips and cheeks.

  • Directions

    Directions: Apply a moderate amount to the lips and cheeks.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    SIERO LABBRA SATIN PINK TASSEL 
    dimethicone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71472-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2.1 g  in 7.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    KAOLIN (UNII: 24H4NWX5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71472-120-021 in 1 CARTON06/01/2017
    1NDC:71472-120-017.5 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2017
    Labeler - JNG KOREA CO.,LTD. (557796103)
    Registrant - JNG KOREA CO.,LTD. (557796103)
    Establishment
    NameAddressID/FEIBusiness Operations
    JNG KOREA CO.,LTD.557796103relabel(71472-120)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689847167manufacture(71472-120)
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