Label: FACE IT POWER PERFECTION 32800312- octinoxate and titanium dioxide 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 • • • • • • • • • • • • 5.0%

    TITANIUM DIOXIDE • • • • • • • • 10.0%

  • Purpose

    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.

    After basic skincare, dispense an adequate amount

    and apply evenly to the skin. Then, pat lightly with the

    palms for full absorption.

  • 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•PHENYL TRIMETHICONE•

    CYCLOHEXASILOXANE•BUTYLENE GLYCOL•ISODODECANE•

    CETYL PEG/PPG-10/1 DIMETHICONE•NIACINAMIDE•

    METHYLPROPANEDIOL•BUTYLENE GLYCOL DICAPRYLATE/

    DICAPRATE•POLYGLYCERYL-4 ISOSTEARATE•SODIUM

    CHLORIDE•HYDROGENATED POLYISOBUTENE•

    DISTEARDIMONIUM HECTORITE•METHYL METHACRYLATE•

    CROSSPOLYMER•SORBITAN ISOSTEARATE•OZOKERITE•

    DIMETHICONE•HEXYL LAURATE•DIMETHICONE/VINYL•

    DIMETHICONE CROSSPOLYMER•HYDROGENATED POLY

    (C6-14 OLEFIN)•CAPRYLIC/CAPRIC GLYCERIDES•

    ETHYLHEXYLGLYCERIN•ALUMINUM HYDROXIDE•BEESWAX•

    STEARIC ACID•TRIETHOXYCAPRYLYLSILANE•FRAGRANCE

    (PARFUM)•PROPYLENE CARBONATE•DISODIUM EDTA•

    PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL•

    RASPBERRY SEED OIL/TOCOPHERYL SUCCINATE

    AMINOPROPANEDIOL ESTERS•ADENOSINE•PORTULACA

    OLERACEA EXTRACT•XANTHAN GUM•SODIUM

    HYALURONATE•PLUKENETIA VOLUBILIS SEED OIL•

    ALUMINA•RETINOL•LINOLEIC ACID•CERAMIDE 3•

    TOCOPHEROL•ASCORBIC ACID•HYDROLYZED EXTENSIN•

    GLYCERIN•SCHINUS TEREBINTHIFOLIUS SEED EXTRACT•

    PHENOXYETHANOL•GYNOSTEMMA PENTAPHYLLUM

    LEAF/STEM•EXTRACT•CALCIUM ALUMINUM BOROSILICATE•

    BETA-GLUCAN•METHYLPARABEN•BUTYLPARABEN•

    ETHYLPARABEN•ISOBUTYLPARABEN•

    PROPYLPARABEN•IRON OXIDES (CI 77491,

    CI 77492, CI 77499)•ZINC OXIDE (CI 77947)

  • 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

    POWER PERFECTION

    BB CREAM

    SUNSCREEN CREAM SPF37

    02 NATURAL BEIGE

    A BB cream providing total skin treatment

    to achieve a "POWER PERFECTION SKIN"

    by imparting proactive care to overall skin problems,

    including bagginess, roughness and dryness.

    Image-label-32800312-rev

  • INGREDIENTS AND APPEARANCE
    FACE IT POWER PERFECTION  32800312
    octinoxate and titanium dioxide cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-312
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 40 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4 g  in 40 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51523-312-051 in 1 CARTON11/20/2014
    140 g 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(51523-312)