Label: NO FOUNDATION FOUNDATION NO.1 FAIR TO LIGHT- 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 April 18, 2014

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 (see Directions) decreases the chance of skin cancer and early skin aging caused by the sun

  • WARNINGS

    Warnings

    For External Use Only

  • DO NOT USE

    Do not use on damaged or broken 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 with your fingertips and blending product in circular motions. Can be re-applied as necessary to build desired coverage.
    • 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 skin aging. To decrease this risk regularly use a sunscreen with a broad spectrum SPF value 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 in this container from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Water/Aqua, Cyclopentasiloxane, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Caprylic/Capric Triglyceride, Titanium Dioxide (CI 77891), Dimethicone, Sorbitan Stearate, Ethylhexyl Palmitate, Cyclohexasiloxane, Aluminum Hydroxide, Stearic Acid, C12-C15 Alkyl Benzoate, Triethoxysilyethyl Polydimethylsiloxyethy Hexyl Dimethicone, Mica, Dimethyl MEA, Tetrahexyldecyl Ascorbate, Phenoxyethanol, Glycolic Acid, Iron Oxides (CI 77491, CI 77492, CI 77499) Caprylyl Glycol, Cetyl Alcohol, Tocopheryl Linoleate/Oleate, Lecithin, Tribehenin, Citric Acid, Xanthan Gum, Ethylhexylglycerin, Hexylele Glycol, PEG-8, Fragrance/Parfum, Polyacrylamide, Sodium Lactate, C13-14 Isoparaffin, Disodium EDTA, Diopotassium Glycyrrhizate, Tocopheryl, Ceramide 2, Pheonix Dactylifera (Date) Fruit Extract, PEG-10 Rapeseed Sterikm Silica Dimethyl Silylate, Laureth-7, Thiotic Acid, Silica, Ascorbyl Palmitate, Limonene, Linalool, Triethoxycaprylylsilane, Ascorbic Acid, Sodium Hyaluronate, Palmitoyl Oligopeptide

  • 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 30ml

  • INGREDIENTS AND APPEARANCE
    NO FOUNDATION FOUNDATION NO.1 FAIR TO LIGHT 
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4063
    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
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    C12-15 Alkyl Benzoate (UNII: A9EJ3J61HQ)  
    MICA (UNII: V8A1AW0880)  
    DEANOL (UNII: 2N6K9DRA24)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    .ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    DATE (UNII: H3O7QI5HY7)  
    PEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LAURETH-7 (UNII: Z95S6G8201)  
    .ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4063-21 in 1 CARTON
    1NDC:62742-4063-130 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/18/2014
    Labeler - Allure Labs, Inc (926831603)