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.
Updated July 2, 2018
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
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
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.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ECO EARTH POWER GREEN SUN
zinc oxide, titanium dioxide cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70341-677 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 5.82 g in 50 g Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 1.56 g in 50 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70341-677-02 1 in 1 CARTON 05/01/2018 1 NDC:70341-677-01 50 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/01/2018 Labeler - The Saem International Co., Ltd. (689402402) Registrant - The Saem International Co., Ltd. (689402402) Establishment Name Address ID/FEI Business Operations Coson Co., Ltd._Osan Plant 689847210 manufacture(70341-677)