Label: FACET IT PURE COLOR CONTROL 32800851- octinoxate, titanium dioxide and zinc oxide cream cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 November 20, 2014

If you are a consumer or patient please visit this version.

  • Active Ingredients

    OCTINOXATE 4.0%
    TITANIUM DIOXIDE 10.2%,
    ZINC OXIDE 1.0%

  • 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.
    Dispense an adequate amount at the last stage of
    your skincare and apply evenly on the face.

    To keep your face looking fresh, use with Face it Aura CC
    Cream.

  • 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•CYCLOHEXASILOXANE•PHENYL
    TRIMETHICONE•GLYCERIN•BUTYLENE GLYCOL DICAPRYLATE/
    DICAPRATE•DIMETHICONE•BUTYLENE GLYCOL•PEG-8•
    NIACINAMIDE•CETYL PEG/PPG-10/1 DIMETHICONE•PENTYLENE
    GLYCOL•SODIUM CHLORIDE•DICAPRYLYL CARBONATE•
    SORBITAN ISOSTEARATE•DISTEARDIMONIUM HECTORITE•
    C30-45 ALKYLDIMETHYLSILYL POLYPROPYLSILSESQUIOXANE•
    PHENOXYETHANOL•DIMETHICONE CROSSPOLYMER•
    TRIETHOXYCAPRYLYLSILANE•ALUMINUM HYDROXIDE•STEARIC
    ACID•ETHYLHEXYLGLYCERIN•ADENOSINE•DISODIUM EDTA•
    VITIS VINIFERA (GRAPE) FRUIT EXTRACT•OENOTHERA BIENNIS
    (EVENING PRIMROSE) OIL•ONSEN-SUI•SODIUM PCA•UREA•
    POLYPERFLUOROMETHYLISOPROPYL ETHER•LONICERA
    JAPONICA (HONEYSUCKLE) FLOWER EXTRACT•IMPERATA
    CYLINDRICA ROOT EXTRACT•TREHALOSE•POLYQUATERNIUM-51•
    CITRUS RETICULATA (TANGERINE) PEEL EXTRACT•
    ACHYRANTHES FAURIEI ROOT EXTRACT•SODIUM
    HYALURONATE•TRIACETIN•CAPRYLYL GLYCOL•1,2-HEXANEDIOL•
    CARBOMER•METHYLPARABEN•POTASSIUM SORBATE•OXYGEN•
    BUTYLPARABEN•ETHYLPARABEN•PROPYLPARABEN•
    ISOBUTYLPARABEN•FRAGRANCE(PARFUM)•
    MICA (CI 77019)•IRON OXIDES (CI 77491,
    CI 77492, CI 77499)

  • Other Information

    Protect the product in this container from excessive heat and
    direct sun.
    May stain or damage some fabrics or surfaces.

  • QUESTIONS

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

  • Distributed by:

    THEFACESHOP NORTH AMERICA, INC.
    Santa Fe Springs, CA 90670

  • PRINCIPAL DISPLAY PANEL

    COLOR CONTROL

    CC

    CREAM

    PURE CC

    SUNSCREEN CREAM SPF30

    02 NATURAL BEIGE

    Image-label-32800851-rev

  • INGREDIENTS AND APPEARANCE
    FACET IT PURE COLOR CONTROL  32800851
    octinoxate, titanium dioxide and zinc oxide cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-851
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.6 g  in 40 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.1 g  in 40 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE.4 g  in 40 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51523-851-291 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 CO., LTD. (688329416)
    Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193)
    Establishment
    NameAddressID/FEIBusiness Operations
    THEFACESHOP Co., Ltd.688329416label(51523-851)