Label: GOLD COLLAGEN AMPOULE FOUNDATION SPF30- titanium dioxide and zinc oxide cream 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 December 31, 2015

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

  • Active Ingredients

    Titanium Dioxide 11.4%

    Zinc Oxide 1.4%

  • Uses

    Helps prevent sunburn

  • Purpose

    Sunscreen

    Sunscreen

  • 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 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, Phenyl Trimethicone, Cyclopentasiloxane, Butylene Glycol, PEG-10 Methyl Ether Dimethicone, Diglycerin, Glycerin, Dicaprylyl Carbonate, Niacinamide, Isononyl Isononanoate, Sodium Chloride, Cyclohexasiloxane, Caprylyl Methicone, Hydrogenated Castor Oil Isostearate, Orbignya Oleifera Seed Oil, Talc, Disteardimonium Hectorite, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Isostearate, Cetyl Dimethicone, 1,2-Hexanediol, Triethyl Citrate, Phenoxyethanol, Caprylyl Glycol, Triethoxycaprylylsilane Hydrolyzed Collagen, Dimethicone/Methicone Copolymer, Ethylhexylglycerin, Adenosine, Ethanol, Hydrogenated Lecithin, Sodium Hyaluronate, Disodium EDTA, Fragrance, Gold, 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 SUNSCREEN FOUNDATION

    N203 NATURAL BEIGE SPF30 PA+++

    ---------------------------------------------------

    High-Coverage Treatment Foundation that contains Gold Collagen Ampoule

    ----------------------------------------------------

    [Helps reduce appearance of wrinkles, brightens skin tone, protects against UV rays]

    • Treatment effects of Gold Collangen Ampoule [Contains 10% gold collagen ampoule]
    • Makes skin appear smoother with its wrinkle covering effect
    • Powerful moisturization for windy days

    Label

  • INGREDIENTS AND APPEARANCE
    GOLD COLLAGEN  AMPOULE FOUNDATION SPF30
    titanium dioxide and zinc oxide cream powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-258
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.6 g  in 40 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.6 g  in 40 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51523-258-091 in 1 CARTON12/31/2015
    140 mL in 1 BOTTLE, PUMP; 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(51523-258)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmecca Korea Co.,Ltd.688830827manufacture(51523-258)