Label: NO FOUNDATION FOUNDATION FAIR- zinc oxide and titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 16, 2013

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:
    Zinc Oxide - 12.2%
    Titanium Dioxide 3.2%

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    

    Uses:

    Helps prevent sunburn if used as directed with other sun protection measures decreases the risk of skin cancer and early skin aging caused by the sun

  • WARNINGS

    Warnings

    For External Use Only

  • DO NOT USE

    Do not use on broken and damaged skin

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove

  • STOP USE

    Stop use and ask doctor if rash ocuur

  • 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. Compatible with all Perricone MD products.
    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Re apply at least every 2 hours.
    • Not for use on children.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including;
      1. Limit time in the sun, especially between 10am to 2pm
    • 2. Wear long sleeved shirts, pants, hats, and sun glasses
  • STORAGE AND HANDLING


    Protect the product from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Aluminum Hydroxide, Accorbic Acid, Ascorbyl Palmitate, Butylene Glycol, C12-C15 Alkyl Benzoate, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide 2, Cetyl Alcohol, Citric Acid, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethyl MEA, Dipotassium Glycyrrhizate, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Palmitate, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Glycolic Acid, Hexylene Glycol, Iron Oxides, Laureth-7, Lecithin, Limonene, Linalool, Mica, Palmitoyl Oligopeptide, PEG-10 Rapseed Sterol, PEG-100 Stearate, P:EG-8, Phenoxyethanol, Phoenix Dactylifera (Date) Fruit Extract, Polyarylamide, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Silica, Silica Dimethyl Siylate, Sodium Hyaluronate, Sodium Lactate, Sorbitan Stearate, Stearic Acid, Tetrahexyldecyl Ascorbate, Thiotic Acid, Titanium Dioxide, Tocopheryl, Tocopheryl Linolate/Oleate, Tribehenin, Triethoxycaprylsilane, Triethoxysilyethyl Polydimethylsiloxyethy Hexyl Dimethicone, Water/Aqua, Xanthan Gum

  • PRINCIPAL DISPLAY PANEL

    Distributed By: NV Perricone LLC, Meriden CT 06450, Made in USA

    NV Perricone MD Cosmeceuticals LTD, London. W1T 3LN UK

    www.perriconemd.com

    1 888 823 7837

    Image of Product: Perricone MD No Foundation Foundation Fair 30mlImage of ther product: Perricone MD No Foundation Foundation Fair 59 ML

  • INGREDIENTS AND APPEARANCE
    NO FOUNDATION FOUNDATION FAIR  
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4060
    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
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DEANOL (UNII: 2N6K9DRA24)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LAURETH-7 (UNII: Z95S6G8201)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MICA (UNII: V8A1AW0880)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    PEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DATE (UNII: H3O7QI5HY7)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4060-21 in 1 CARTON
    1NDC:62742-4060-130 mL in 1 BOTTLE, PUMP
    2NDC:62742-4060-41 in 1 CARTON
    2NDC:62742-4060-359 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/16/2013
    Labeler - Allure Labs, Inc (926831603)