Label: GOLD COLLAGEN AMPOULE COVER CAKE SPF50 N203- octinoxate, octisalate, titanium dioxide and zinc oxide cream powder

  • Category: HUMAN OTC DRUG LABEL

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 August 10, 2015

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  • Active Ingredients

    Octinoxate 6.0 %
    Octisalate 2.0 %
    Titanium Dioxide 15.4 %
    Zinc Oxide 4.9 %

  • Purpose

    Sunscreen
    Sunscreen
    Sunscreen
    Sunscreen

  • Uses

    Helps prevent sunburn

  • Warnings

    For external use only.

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply generously and evenly 15 minutes before sun exposure.
    Children under 6 months of age: Ask a doctor.
    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
    Reapply at least every 2 hours.
    Use a water-resistant sunscreen if swimming or sweating.

    Dispense an adequate amount onto the puff and apply to skin. Pat skin lightly to boost absorption.

  • Other Information

    Protect the product in this container from excessive heat and direct sun.

    May stain or damage some fabrics or surfaces.

  • Inactive Ingredients

    Water, Cyclopentasiloxane, Diphenylsiloxy Phenyl Trimethicone, Cyclohexasiloxane, Ceresin, Butylene Glycol, Dicaprylyl Carbonate, Butylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone, Dimethicone, Polyethylene, Glycerin, Niacinamide, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Caprylyl Methicone, Pentylene Glycol, PEG-32, Sorbitan Isostearate, Aluminum Hydroxide, Magnesium Sulfate, Stearic Acid, Phenoxyethanol, Dimethicone Crosspolymer, Silica, Triethoxycaprylylsilane, Disteardimonium Hectorite, 1,2-Hexanediol, Sorbitan Olivate, Hydrolyzed Collagen, Ethylhexylglycerin, Adenosine, Disodium EDTA, Sodium Hyaluronate, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Centella Asiatica Extract, Portulaca Oleracea Extract, Fragrance, Gold (CI 77480), Mica (CI 77019), Iron Oxides (CI 77491, CI 77492, CI 77499)

  • QUESTIONS

    Questions or comments? Call 1-866-638-8417

  • Distributed by:

    THEFACESHOP NORTH AMERICA, INC.

    Santa Fe Springs, CA 90670

  • PRINCIPAL DISPLAY PANEL

    THEFACESHOP GOLD COLLAGEN
    AMPOULE COVER CAKE SUNSCREEN FOUNDATION
    N203 NATURAL BEIGE SPF50+ PA+++
    Highly-nourishing Treatment Cover Cake Foundation
    with Gold Collagen Ampoule
    [Triple-Function Cosmetic Care (Wrinkle Appearance Reduction, Brightening, UV Protection) Cosmetic]
    Benefits of Gold Collagen Ampoule
    [Contains 10% gold collagen ampoules]
    Makes skin appear smoother with its wrinkle covering effect
    Smooth cream texture for coverage that moisturizes and nourishes

    Label

  • INGREDIENTS AND APPEARANCE
    GOLD COLLAGEN  AMPOULE COVER CAKE SPF50 N203
    octinoxate, octisalate, titanium dioxide and zinc oxide cream powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-260
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.7 g  in 11 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.5 g  in 11 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.7 g  in 11 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.2 g  in 11 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51523-260-111 in 1 CARTON12/31/2015
    111 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 finalpart35212/31/2015
    Labeler - THEFACESHOP CO., LTD. (688329416)
    Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193)
    Establishment
    NameAddressID/FEIBusiness Operations
    THEFACESHOP CO., LTD.688329416label(51523-260)