Label: NO FOUNDATION SPF 30- 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 31, 2013

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  • 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 Cosmeceuticals LTD

    London, W1T 3LN UK

    www.perriconemd.com

    1 888 823 7837

    IMAGE OF THE PRODUCT:

    Image of Product: 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:62742-4061
    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)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    2-(DIETHYLAMINO)ETHANOL (UNII: S6DL4M053U)  
    MICA (UNII: V8A1AW0880)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALPHA-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    ALPHA LIPOIC ACID (UNII: 73Y7P0K73Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    ACRYLAMIDE (UNII: 20R035KLCI)  
    LEMON OIL (UNII: I9GRO824LL)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    DATE (UNII: H3O7QI5HY7)  
    TEPRENONE (UNII: S8S8451A4O)  
    LINALOOL, D- (UNII: F4VNO44C09)  
    LAURETH-7 (UNII: Z95S6G8201)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CLARY SAGE (UNII: U3HSK5JC0Q)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    GUAIAC OIL (UNII: 81H0L6W02F)  
    CORIANDER OIL (UNII: 7626GC95E5)  
    CLOVE OIL (UNII: 578389D6D0)  
    WHEAT BRAN (UNII: 6L966A1IMR)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    VIOLA ODORATA (UNII: AET12U8B74)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4061-21 in 1 CARTON
    1NDC:62742-4061-159 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/31/2013
    Labeler - Allure Labs, Inc. (926831603)
    Registrant - Allure Labs, Inc. (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs, Inc.926831603manufacture(62742-4061)
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