15HR COVER LASTING SPF50 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE AND ZINC OXIDE CREAM) CREAM [THEFACESHOP CO., LTD.]

15HR COVER LASTING SPF50 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE AND ZINC OXIDE CREAM) CREAM [THEFACESHOP CO., LTD.]
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NDC 51523-371-23
Set ID 2047cc56-89e2-4aa1-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager THEFACESHOP CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Octinoxate 7.0 %

    Octisalate 4.5 %

    Titanium Dioxide 11.5 %

    Zinc Oxide 4.9 %

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  • Purpose

    Sunscreen

    Sunscreen

    Sunscreen

    Sunscreen

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  • Uses

    Helps prevent sunburn.

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  • 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.

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  • 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.

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  • Other Information

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

    May stain or damage some fabrics or surfaces.

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  • Inactive Ingredients

    Chamomilla Recutita (Matricaria) Flower Water, Cyclopentasiloxane, Trimethylsiloxysilicate, Cyclohexasiloxane, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Cetyl PEG/PPG-10/1 Dimethicone, Glycerin, Niacinamide, Methylpropanediol, Pentylene Glycol, Hydrogenated Polyisobutene, Polyglyceryl-4 Isostearate, Disteardimonium Hectorite, Phenyl Trimethicone, Sorbitan Isostearate, Magnesium Sulfate, Phenoxyethanol, Ozokerite, Dimethicone, Hexyl Laurate, Aluminum Hydroxide, Stearic Acid, Dimethicone Crosspolymer, Saccharomyces Ferment, Triethoxycaprylylsilane, Beeswax, Ethylhexylglycerin, Disodium EDTA, Adenosine, Xanthan Gum, Hydrogenated Castor Oil Isostearate, Volcanic Ash, Chenopodium Quinoa Seed Extract, Water, Rubus Chamaemorus Seed Extract, Fragrance, Mica (CI 77019), Iron Oxides (CI 77492, CI 77499, CI 77491)

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  • QUESTIONS

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

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  • Distributed by:

    THEFACESHOP NORTH AMERICA, INC.

    Santa Fe Springs, CA 90670

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  • PRINCIPAL DISPLAY PANEL

    THEFACESHOP

    15HR COVER LASTING SUNSCREEN FOUNDATION

    N203 NATURAL BEIGE

    SPF50+ PA+++

    The flawless foundation lasts fresh for up to 15 hours.

    15 hours coverage

    Creates a deeply moisturizing layer on skin.

    Contains 40% glow serum with Smart Seed extract.

    Label

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  • INGREDIENTS AND APPEARANCE
    15HR COVER LASTING  SPF50
    octinoxate, octisalate, titanium dioxide and zinc oxide cream cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-371
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.45 g  in 35 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.58 g  in 35 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.03 g  in 35 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.72 g  in 35 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51523-371-23 1 in 1 CARTON 10/01/2015
    1 35 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 10/01/2015
    Labeler - THEFACESHOP CO., LTD. (688329416)
    Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193)
    Establishment
    Name Address ID/FEI Business Operations
    THEFACESHOP CO., LTD. 688329416 label(51523-371)
    Establishment
    Name Address ID/FEI Business Operations
    COSMAX INC. 689019313 manufacture(51523-371)
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