Label: BARE SKIN NUDE NATURAL BEIGE SPF30- octinoxate and octisalate cream cream

  • Category: HUMAN OTC DRUG LABEL

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 September 18, 2015

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  • Active Ingredients

    Octinoxate 6.0%

    Octisalate 2.0%

  • 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.

    Dispense an adequate amount and apply to skin. Pat skin lightly to boost 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

    CHAMOMILLA RECUTITA (MATRICARIA) FLOWER WATER, CYCLOPENTASILOXANE, TITANIUM DIOXIDE, PROPYLENE GLYCOL, ISODODECANE, ETHYL ALCOHOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, TALC, HYDROGENATED POLY(C6-14 OLEFIN), NIACINAMIDE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIDECYL TRIMELLITATE, ZINC OXIDE, BUTYLENE GLYCOL, DIMETHICONE, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, DISTEARDIMONIUM HECTORITE, PEG-10 DIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, MAGNESIUM SULFATE, BETAINE, PORTULACA OLERACEA EXTRACT, 1,2-HEXANEDIOL, PHENOXYETHANOL, ALUMINUM HYDROXIDE, AMINOPROPYL DIMETHICONE, ALUMINUM STEARATE, METHICONE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, POLYMETHYLSILSESQUIOXANE, ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, ALUMINA, ADENOSINE, SILICA, TRIETHOXYCAPRYLYLSILANE, RUBUS CHAMAEMORUS SEED EXTRACT, VOLCANIC ASH, WATER, CHENOPODIUM QUINOA SEED EXTRACT, FRAGRANCE, IRON OXIDES(CI 77491, CI 77492, CI 77499)

  • QUESTIONS

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

  • Distributed by:

    THEFACESHOP NORTH AMERICA, INC.

    Santa Fe Springs, CA 90670

  • PRINCIPAL DISPLAY PANEL

    THEFACESHOP

    BARE SKIN NUDE SUNSCREEN

    FOUNDATION

    N203 NATURAL BEIGE

    SPF30 PA++

    Our foundation makes skin look naturally bright and smooth.

    •Natural glow makeup

    •Provides the long-wearing e­ect of a tightly adhering foundation

    •Contains over 22% of smooth-looking skin serum with Perfect Seed*

    Label

  • INGREDIENTS AND APPEARANCE
    BARE SKIN  NUDE NATURAL BEIGE SPF30
    octinoxate and octisalate cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-368
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.7 g  in 35 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 g  in 35 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51523-368-201 in 1 CARTON10/01/2015
    135 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 finalpart35210/01/2015
    Labeler - THEFACESHOP CO., LTD. (688329416)
    Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193)
    Establishment
    NameAddressID/FEIBusiness Operations
    THEFACESHOP CO., LTD.688329416label(51523-368)