Label: ECO EARTH POWER GREEN SUN- zinc oxide, titanium dioxide cream

  • NDC Code(s): 70341-677-01, 70341-677-02
  • Packager: The Saem International Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 July 2, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients: Zinc Oxide 11.64%, Titanium Dioxide 3.12%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Cyclomethicone, Propanediol, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dibutyl Adipate, Caprylyl Methicone, 1,2-Hexanediol, Disteardimonium Hectorite, Magnesium Sulfate, Undecane, Hydrogen Dimethicone, Trehalose, Aluminum Hydroxide, Salvia Hispanica Seed Extract, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Polyglyceryl-2 Dipolyhydroxystearate, Centella Asiatica Extract, Houttuynia Cordata Extract, Tridecane, Stearic Acid, Fructooligosaccharides, Saccharide Hydrolysate, Helianthus Annuus (Sunflower) Seed Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Olea Europaea (Olive) Fruit Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Ethylhexylglycerin, Pullulan, Octyldodecanol, Pelargonium Graveolens Flower Oil, Lepidium Meyenii Root Extract, Anthemis Nobilis Flower Water, Lavandula Angustifolia (Lavender) Oil, Glycerin, Panthenol, Echium Plantagineum Seed Oil, Rosa Damascena Flower Oil, Butylene Glycol, Moringa Oleifera Seed Oil, Ocimum Basilicum (Basil) Oil, Alcohol, Epilobium Angustifolium Flower/Leaf/Stem Extract, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Ceramide NP, Tocopherol, Phytosphingosine, Pentylene Glycol, Madecassoside, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Hydrogenated Lecithin, Averrhoa Carambola Fruit Extract, Moringa Pterygosperma Seed Extract, Maltodextrin

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings:

    For external use only

    1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.

    1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.

    2) In case of having the same symptoms above on the part you put this product on by direct sunlight.

    2. You are banned to use it on the part where you have a scar, eczema, or dermatitis.

    3. In case of getting it into your eyes, you have to wash it immediately.

    4. Keep out of reach of babies and children.

  • DESCRIPTION

    Uses:

    Helps prevent sunburn.

    Directions:

    At the last step of skin care, apply on the skin area exposed to UV rays.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ECO EARTH POWER GREEN SUN 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70341-677
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION5.82 g  in 50 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.56 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70341-677-021 in 1 CARTON05/01/2018
    1NDC:70341-677-0150 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 finalpart35205/01/2018
    Labeler - The Saem International Co., Ltd. (689402402)
    Registrant - The Saem International Co., Ltd. (689402402)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coson Co., Ltd._Osan Plant689847210manufacture(70341-677)