Label: GOLD COLLAGEN FOUNDATION SPF30- octinoxate, 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 September 28, 2015

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  • Active Ingredients:


    Octinoxate 5.0 %
    Titanium Dioxide 14.0 %
    Zinc Oxide 2.9 %

  • Purpose

    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 SAFETY INFORMATION

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

    May stain or damage some fabrics or surfaces.

  • INACTIVE INGREDIENT

    Silica, Talc, Nylon-12, Boron Nitride, Hexyl Laurate, HDI/Trimethylol Hexyllactone Crosspolymer, Triethoxycaprylylsilane, Aluminum Dimyristate, Methicone, Dimethicone, Ethylhexylglycerin, Caprylyl Glycol, Water, 1,2-Hexanediol, Hydrolyzed Collagen, Squalane, Sodium Hyaluronate, Helianthus Annuus (Sunflower) Seed Oil, Butylene Glycol, 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

    GOLD COLLAGEN

    AMPOULE TWO-WAY COMPACT SUNSCREEN FOUNDATION

    N205 DARK BEIGE SPF30 PA+++

    Label

  • INGREDIENTS AND APPEARANCE
    GOLD COLLAGEN  FOUNDATION SPF30
    octinoxate, titanium dioxide and zinc oxide cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-466
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.48 g  in 9.5 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.33 g  in 9.5 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.28 g  in 9.5 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51523-466-331 in 1 CARTON10/01/2015
    19.5 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 finalpart35210/01/2015
    Labeler - THEFACESHOP CO., LTD. (688329416)
    Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193)
    Establishment
    NameAddressID/FEIBusiness Operations
    THEFACESHOP CO., LTD.688329416label(51523-466)
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