ECO BARRIER NON CHEMICAL SUN (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [JEIL H&B INC.]

ECO BARRIER NON CHEMICAL SUN (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [JEIL H&B INC.]
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NDC 71982-010-01, 71982-010-02
Set ID 8bb05876-d3c4-4fcd-9c56-573471d9c9b0
Category HUMAN OTC DRUG LABEL
Packager JEIL H&B INC.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients: Zinc Oxide 10%, Titanium Dioxide 8%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Cyclomethicone, Propanediol, Dicaprylyl Carbonate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cetyl Ethylhexanoate, Aluminum Hydroxide, 1,2-Hexanediol, Disteardimonium Hectorite, Hydrogen Dimethicone, Magnesium Sulfate, Salvia Hispanica Seed Extract, Stearic Acid, Centella Asiatica Extract, Houttuynia Cordata Extract, Polyglyceryl-2 Dipolyhydroxystearate, Dimethicone Crosspolymer, Phenyl Trimethicone, Lavandula Angustifolia (Lavender) Oil, Fructooligosaccharides, Saccharide Hydrolysate, Pullulan, Water, Ethylhexylglycerin, Octyldodecanol, Hydrogenated Lecithin, Echium Plantagineum Seed Oil, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Butylene Glycol, Caprylyl Glycol, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Sorbitan Sesquioleate, Cholesterol, Phytosphingosine, Ceramide EOP, Ceramide NS, Ceramide NP, Ceramide AP, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Chamomilla Recutita (Matricaria) Flower Oil, Tocopherol, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Sodium Hyaluronate

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children.

  • DESCRIPTION

    Uses: Hypoallergenic sun cream for children and easily irritated sensitive skin. The natural 100% mineral filter forms a physical barrier to reflect UV light from the surface of the skin. With a skin-friendly moisturizing formula, this sun cream smoothes into the skin easily and protects the skin from external stimuli like fine dust. This mild sun cream is suitable for all skin types, decreases the risk of skin cancer and early skin aging caused by the sun.

    Directions:

    Apply liberally 15 minutes before sun exposure

    Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours

    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses

    Children under 6 months: Ask a doctor

    Questions: www.nislcos.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ECO BARRIER NON CHEMICAL SUN 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71982-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION5.0 g  in 50 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide4.0 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propanediol (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71982-010-021 in 1 CARTON12/01/2017
    1NDC:71982-010-0150 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 finalpart35212/01/2017
    Labeler - JEIL H&B INC. (694788123)
    Registrant - JEIL H&B INC. (694788123)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSON Co., Ltd._Osan Plant689847210manufacture(71982-010)

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