Label: AGATHA FITTING TOUCH MAKE UP SET- octinoxate, titanium dioxide, octisalate, zinc oxide powder

  • 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

    Active Ingredient: Ethylhexyl Methoxycinnamate 7.5%, Titanium Dioxide 8.65755%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 3.52%

  • 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

    Purpose: Sunscreen

  • 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

    How to use: Once an appropriate amount has accumulated, use the included puff to smooth it out onto your face by patting it in an outward motion.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    AGATHA FITTING TOUCH MAKE UP SET 
    octinoxate, titanium dioxide, octisalate, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62171-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.67 g  in 9 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.77 g  in 9 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.45 g  in 9 g
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.31 g  in 9 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62171-070-019 g in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2015
    Labeler - Coson Co., Ltd. (689835593)
    Registrant - Coson Co., Ltd. (689835593)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coson Co., Ltd.689835593manufacture(62171-070)