Label: AGATHA FITTING TOUCH MAKE UP SET- octinoxate, titanium dioxide, octisalate, zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 62171-070-01 - Packager: Coson 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 January 13, 2016
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
AGATHA FITTING TOUCH MAKE UP FOUNDATION PACT - Inactive Ingredients: Water, Cyclopentasiloxane, Cyclohexasiloxane, Butylene Glycol, PEG-10 Dimethicone, Trimethylsiloxysilicate, Phenyl Trimethicone, Glycerin, Niacinamide, Diglycerin, Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone, Polymethylsilsesquioxane, Disteardimonium Hectorite, Diisostearyl Malate, Sodium Chloride, Sorbitan Sesquioleate, Helianthus Annuus (Sunflower) Seed Oil, Oenothera Biennis(Evening Primrose) Oil, Anthemis Nobilis Flower Water, Rosa Damascena Flower Water, Panax Ginseng Root Extract, Tocopherol, Centella Asiatica Extract, Sodium Hyaluronate, Olea Europaea(Olive) Fruit Oil, Lecithin, Lilium Candidum Flower Extract, Leontopodium Alpinum Flower/Leaf Extract, Convallaria Majalis Bulb/Root Extract, Magnolia Liliflora Flower Extract, Phytosterols, Squalane, Hydrolyzed Collagen, Tocopheryl Acetate, Paeonia Lactiflora Root Extract, Hydrolyzed Pea Protein, Saussurea Involucrata Extract, Citrus Aurantium Dulcis(Orange) Flower Extract, Dioscorea Japonica Root Extract, Plumeria Rubra Flower Extract, Tremella Fuciformis (Mushroom) Extract, Butyrospermum Parkii(Shea Butter), Ceramide 3, Mica(CI77019), Polymethyl Methacrylate, Aluminum Hydroxide, Ozokerite, Polyhydroxystearic Acid, Dimethicone, Stearic Acid, Triethoxycaprylylsilane, Dimethicone Crosspolymer, Disodium EDTA, Adenosine, Linoleic Acid, Phenoxyethanol, Ethylhexylglycerin, 1,2-Hexanediol, Iron Oxides(CI77492), Iron Oxides(CI77491), Iron Oxides(CI77499), Fragrance
AGATHA TINTED LIP GLOW - Ingredients: Diisostearyl Malate, Limnanthes Alba(Meadowfoam) Seed Oil, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Hydrogenated Polyisobutene, Methyl Hydrogenated Rosinate, Hydrogenated Castor Oil Dimer Dilinoleate, Synthetic Fluorphlogopite, Hydrogenated Vegetable Oil, Astrocaryum Murumuru seed Butter, Euphorbia Cerifera(Candelilla) Wax, Polyethylene, Butyrospermum Parkii(Shea Butter), Tocopheryl Acetate, Ceresin, Ethylene/Propylene Copolymer, Synthetic Wax, Copernicia Cerifera(Carnauba) Wax, Sucrose Tetrastearate Triacetate, Triethoxycaprylylsilane, Fragrance, Red 27 (CI45410:1)
- PURPOSE
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WARNINGS
Warnings: 1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itching, irritation, or symptoms where product has been applied under direct sunlight. 2. Do not use on scarred skin or if you have dermatitis or eczema. 3. Keep the cap closed on this product. 4. Keep away from direct sunlight or heat. 5. Keep out of reach of children.
- How to use
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AGATHA FITTING TOUCH MAKE UP SET
octinoxate, titanium dioxide, octisalate, zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62171-070 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 0.67 g in 9 g Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 0.77 g in 9 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 0.45 g in 9 g Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.31 g in 9 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62171-070-01 9 g in 1 CARTON; 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 12/01/2015 Labeler - Coson Co., Ltd. (689835593) Registrant - Coson Co., Ltd. (689835593) Establishment Name Address ID/FEI Business Operations Coson Co., Ltd. 689835593 manufacture(62171-070)