Label: SONATURAL POW DER4ROOM SMUDGING ZERO REMOVER- dimethicone stick

  • 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 March 23, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: Dimethicone 12.1%

  • INACTIVE INGREDIENT

    Inactive ingredients: Isotridecyl Isononanoate, Caprylic/Capric Triglyceride, Triethylhexanoin, Ethylhexyl Palmitate, Stearyl Dimethicone, Ceresin, Diisostearyl Malate, Sorbitan Sesquioleate, Octyldodecanol, Euphorbia Cerifera (Candelilla) Wax, Phenyl Trimethicone, Zinc Stearate, Polyethylene, Microcrystalline Wax, Disteardimonium Hectorite, Ethylhexyl Methoxycinnamate, Propylene Carbonate, Glyceryl Caprylate, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Mangifera Indica (Mango) Seed Butter, Simmondsia Chinensis (Jojoba) Seed Oil, Argania Spinosa Kernel Oil, Rosa Canina Fruit Oil, Mica (CI 77019), Titanium Dioxide (CI 77891), Red 7 Lake (CI 15850:1)

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: 1. If the following symptoms occur, discontinue use and consult a dermatologist: 1) Red spots, swelling, itchiness, or irritation upon use 2) If above symptoms occur when skin is in direct sunlight 2. Do not use on open wounds and on skin with eczema or dermatitis 3. Storage instructions: 1) Close lid tightly after each use 2) Keep out of reach of children 3) Store at room temperature away from direct sunlight 4. Eye makeup products 1) Rinse with water immediately if contact with eyes.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indications & Usage: Rub gently on eye areas by pink remover if desired to remove or fix make up and then wipe it out with soft sponge tip.

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Get appropriate amount of pink remover, rub gently on eye areas and then wipe it out with soft sponge tip.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    SONATURAL POW DER4ROOM SMUDGING ZERO REMOVER 
    dimethicone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71322-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.18 g  in 1.5 g
    Inactive Ingredients
    Ingredient NameStrength
    Isotridecyl Isononanoate (UNII: WEF51750MT)  
    Triethylhexanoin (UNII: 7K3W1BIU6K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71322-070-021 in 1 CARTON03/02/2017
    1NDC:71322-070-011.5 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/02/2017
    Labeler - Sonatural Global Co.,Ltd (694818511)
    Registrant - Sonatural Global Co.,Ltd (694818511)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sonatural Global Co.,Ltd694818511manufacture(71322-070)