FACE IT 32800285 (OCTINOXATE, TITANIUM OXIDE AND ZINC OXIDE CREAM) CREAM [THEFACESHOP NORTH AMERICA, INC.]

FACE IT 32800285 (OCTINOXATE, TITANIUM OXIDE AND ZINC OXIDE CREAM) CREAM [THEFACESHOP NORTH AMERICA, INC.]
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NDC 51523-285-03
Set ID 07d4e9a6-8731-5c4f-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager THEFACESHOP NORTH AMERICA, INC.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    OCTINOXATE.......... .5.5%

    TITANIUM DIOXIDE .5.7%

    ZINC OXIDE ............. 3.0%

  • 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.

    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.

  • Directions

    Apply generously and evenly 15 minutes before sun exposure.

    Children under 6 months of age: Ask a doctor

    Reapply at least every 2 hours.

    Use a water-resistant sunscreen if swimming or sweating.

  • 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•MICA•

    TRIETHOXYCAPRYLYLSILANE•DIPROPYLENE

    GLYCOL•PROPYLENE GLYCOL•PHENYL

    TRIMETHICONE•DIMETHICONE CROSSPOLYMER•

    LAURYL PEG-8 DIMETHICONE•SILICA•METHICONE•

    DIMETHICONE•DIMETHICONE/VINYL DIMETHICONE

    CROSSPOLYMER•DISTEARDIMONIUM HECTORITE•

    POLYGLYCERYL-6 POLYRICINOLEATE•MANNAN•

    SODIUM CHLORIDE•LECITHIN•PROPYLENE

    CARBONATE•CITRUS PARADISI(GRAPEFRUIT)

    FRUIT EXTRACT•METHYLPARABEN•DISODIUM

    EDTA•AMETHYST POWDER•RUBY POWDER•

    QUARTZ•NEPHRITE POWDER•SAPPHIRE POWDER•

    TOURMALINE•BUTYLENE GLYCOL•CENTELLA

    ASIATICA EXTRACT•CAMELLIA SINENSIS LEAF

    EXTRACT•HEDERA HELIX (IVY) LEAF/STEM

    EXTRACT•ANTHEMIS NOBILIS FLOWER EXTRACT•

    FRAGRANCE•IRON OXIDES

    (CI 77491, CI 77492, CI 77499)

  • QUESTIONS

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

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    THEFACESHOP NORTH AMERICA, INC.

    Santa Fe Springs, CA 90670

  • PRINCIPAL DISPLAY PANEL

    SHIMMERING BB CREAM

    SUNSCREEN CREAM SPF20

    This BB cream contains "Crystal Modeling Powder" which offers a

    radian, luminous complexion and "Jewel Repair Complex" which is

    a skin repair complex that keeps skin healthy.

    Image-label-32800285-rev

  • INGREDIENTS AND APPEARANCE
    FACE IT  32800285
    octinoxate, titanium oxide and zinc oxide cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-285
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.2 g  in 40 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.28 g  in 40 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.2 g  in 40 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51523-285-031 in 1 CARTON11/20/2014
    140 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/20/2014
    Labeler - THEFACESHOP NORTH AMERICA, INC. (688329416)
    Registrant - THEFACESHOP CO., LTD. (688329416)
    Establishment
    NameAddressID/FEIBusiness Operations
    THEFACESHOP Co., Ltd.688329416label(51523-285)

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