FACE IT 32800378 (OCTINOXATE, TITANIUM OXIDE AND ZIND OXIDE CREAM) CREAM [THEFACESHOP CO., LTD.]

FACE IT 32800378 (OCTINOXATE, TITANIUM OXIDE AND ZIND OXIDE CREAM) CREAM [THEFACESHOP CO., LTD.]
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NDC 51523-378-06
Set ID 07d78c56-a6cf-4d69-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager THEFACESHOP CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    OCTINOXATE • • • • • • • 7.3%

    TITANIUM DIOXIDE • • • 15.0%

    ZINC OXIDE • • • • • • • • 5.9%

  • Purpose

    Sunscreen

    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.

    Shake lightly 3 – 5 times before use. Dispense an

    adequate amount and apply evenly to the skin. Then,

    pat lightly with fingers for full absorption. Re-apply a

    small amount to parts that require extra coverage and

    pat with fingers.

    Double cleansing is recommended as this product

    adheres tightly to the skin. FACE IT One-ste p BB

    Cleanser may be used for simple and easy cleansing.

  • Other information

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

    May stain or damage some fabrics or surfaces.

  • Inactive Ingredients

    CYCLOPENTASILOXANE•WATER•BUTYLENE GLYCOL•

    DIMETHICONE•SD ALCOHOL 40-B•HDI/TRIMETHYLOL

    HEXYLLACTONE CROSSPOLYMER•CAPRYLIC/CAPRIC

    GLYCERIDES•ISOHEXADECANE•SODIUM CHLORIDE•

    ALUMINUM HYDROXIDE•METHYL METHACRYLATE

    CROSSPOLYMER•STEARIC ACID•PEG-10 DIMETHICONE•

    1,2-HEXANEDIOL•TRIETHOXYCAPRYLYLSILANE•SILICA•

    DISODIUM EDTA•ALOE BARBADENSIS LEAF EXTRACT•

    PORTULACA OLERACEA EXTRACT•ADANSONIA DIGITATA

    SEED EXTRACT•ALCOHOL•PHENOXYETHANOL•

    METHYLPARABEN•PROPYLPARABEN•ETHYLPARABEN•

    BUTYLPARABEN•ISOBUTYLPARABEN•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

    BB

    SUNSCREEN

    CREAM

    SPF50+

    01 LIGHT

    BEIGE

    Image-label-32800378-rev

  • INGREDIENTS AND APPEARANCE
    FACE IT  32800378
    octinoxate, titanium oxide and zind oxide cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-378
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate3.65 g  in 50 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide7.5 g  in 50 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide2.95 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51523-378-061 in 1 CARTON11/20/2014
    150 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 CO., LTD. (688329416)
    Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193)
    Establishment
    NameAddressID/FEIBusiness Operations
    THEFACESHOP Co., Ltd.688329416label(51523-378)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMAX INC.689019313manufacture(51523-378)

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