Label: NO FOUNDATION SPF 30- zinc oxide and titanium dioxide 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 August 2, 2010

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    Zinc Oxide 12.2%

    Titanium Dioxide 3.2%

  • PURPOSE


    PURPOSE:

    Sunscreen

  • INDICATIONS & USAGE


    USES:

    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
  • WARNINGS

    WARNINGS:

    • For external use only
  • WHEN USING

    WHEN USING THIS PRODUCT:

    • Keep out of eyes. Rinse with water to remove.
  • STOP USE

    STOP USE AND ASK A DOCTOR IF

    • Rash or irritation develops and lasts.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE


    DIRECTIONS:

    • Dr. Perricone recommends applying evenly in gentle circular motions on top of treatment and or moisturizer. Can be re-applied as necessary. Compatible with all Perricone MD products.
    • Not for use on children.
  • STORAGE AND HANDLING

    STORAGE:

    • Store at room temperature.
    OTHER INFORMATION:
    • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.
    • Lot No. and exp date: See bottom of carton.
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:

    Aqua (Water), Cyclopentasiloxane, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Tetrahexyldecyl Ascorbate, C12-15 Alkyl Benzoate, Dimethicone, Sorbitan Stearate, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Cyclohexasiloxane, Iron Oxides (77499, 77491, 77492), Glycolic Acid, Dimethyl MEA (DMAE), Mica, Phenoxyethanol, Citric Acid, Tribehenin, Caprylyl Glycol, Lecithin, Cetyl Alcohol, Tocopheryl Linoleate/Oleate, Thioctic Acid (Alpha-Lipoic Acid), Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Hexylene Glycol, Ethylhexylglycerin, Xanthan Gum, PEG-8, Triethoxysilylethyl Polydimethylsilxyethyl Hexyl Dimethicone, Polyacrylamide, Citrus Medica Limonum (Lemon) Peel Oil, Limonene, Sodium Lactate, Ceramide-2, Aluminum Hydroxide, Stearic Acid, C13-14 Isoparaffin, PEG-10 Rapeseed Sterol, Disodium EDTA, Dipotassium Glycyrrhizate, Tocopherol, Phoenix Dactylifera (Date) Fruit Extract, Silica Dimethyl Silylate,  Teprenone, Triethoxycaprylylsilane, Linalool, Laureth-7, Silica, Ascorbyl Palmitate, Hyaluronic Acid, Ascorbic Acid, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Palmitoyl Oligopeptide, Salvia Sclarea (Clary) Extract, Cedrus Atlantica Bark Oil, Ilex Paraguariensis Leaf Extract, Bulnesia SarmientoiWood Oil, Coriandrm Sativum (Coriander) Fruit Oil, Salvia Sclarea (Clary) Oil, Eugenia Caryophyllus (Clove) Flower Oil, Triticum Vulgare (Wheat) Bran Extract, Anthemis Nobilis Flower Oil, Jasminum Officinale (Jasmine) Oil, Viola Odorata Flower/Leaf Extract.

  • PRINCIPAL DISPLAY PANEL


    DISTRIBUTOR (US):

    NV Perricone LLC

    Meriden CT 06450


    DISTRIBUTOR (UK)

    NV Perricone MD Cosmecuticals LTD

    London, W1D 2EU UK

    www.perriconemd.com

    1 888 823 7837


    IMAGE OF THE PRODUCT:

    Image of Tube 7.5mL: Perricone MD No Foundation SPF30




  • INGREDIENTS AND APPEARANCE
    NO FOUNDATION SPF 30 
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4048
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE122 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE32 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4048-17.5 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2010
    Labeler - Allure Labs, Inc. (926831603)
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