Label: GOLD COLLAGEN SPF 30 PA- titanium dioxide and zinc oxide cream cream

  • 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 January 1, 2016

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredients

    Titanium Dioxide 11.4%

    Zinc Oxide 1.4%

  • Purpose

    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 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, Orbignya Oleifera Seed Oil, Hydrogenated Castor Oil Isostearate, Talc, Disteardimonium Hectorite, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Isostearate, Cetyl Dimethicone, 1,2-Hexanediol, Triethyl Citrate, Phenoxyethanol, Caprylyl Glycol, Triethoxycaprylylsilane, Hydrolyzed Collagen, Hydrogen Dimethicone, 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

    V201 APRICOT BEIGE

    SPF30 PA++

    label-34200257

  • INGREDIENTS AND APPEARANCE
    GOLD COLLAGEN  SPF 30 PA
    titanium dioxide and zinc oxide cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-257
    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:51523-257-081 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(51523-257)