Label: NO CONCEALER CONCEALER NO.2 LIGHT TO MEDIUM- titanium dioxide and zinc oxide 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 11, 2014

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Titanium Dioxide 4.8%

    Zinc Oxide 5.88%

  • 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 sun.
  • WARNINGS

    Warning:

    • 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 occurs.

  • 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 along the lower eye contours. Gently Blend with fingertips and smooth outward. Any excess can also be applied on targeted areas of the face to cover imperfections.

  • STORAGE AND HANDLING

    Protect the product in this container from excessive heat and direct sun

  • INACTIVE INGREDIENT

    Cyclopentasiloxane, Water/Aqua, Dimethicone/PEG-10/15 Crosspolymer, Mica, Cyclotetrasiloxane, Dimethicone, Sodium PCA, Glycerin, Nylon-12, PPG-12 SMDI Copolymer, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone,C12-15 Alkyl Benzoate, Iron Oxides (CI77491, CI 77492, CI 77499), Aluminum Hydroxide, Stearic Acid, Tocopheryl Acetate, Glucosyl Hesperidin, Ethylhexyl Palmitate, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-4 Isostearate, PEG/PPG-18/18 Dimethicone, Tetrahexyldecyl Ascorbate, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Hexyl Laurate, Tribehenin, Cetearyl Olivate, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Caprylyl Glycol, Propylene Glycol, Sorbitan Olivate, Hexylene Glycol, Ethylhexylglycerin, Triethoxycaprylylsilane, Steareth-20, Ceramide 2, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Dimethyl MEA, PEG-10 Rapeseed Sterol, Silica, Silica DimethylSilylate, Butylene Glycol, Hydroxypropyl Cyclodextrin, Hydoxysuccinimide, Hyaluronic Acid, Palmitoyl Oligopeptide, Palmitoyl Tripeptide-38, Chrysin, Plamitoyl tetrapeptide-7

  • PRINCIPAL DISPLAY PANEL

    Distributed By (US): NV Perricone LLC Meriden CT 06450 Made in USA

    Distributed By (UK): NV Perricone MD Cosmeceuticals Ltd London W1T 3LN UK

    www.perriocnemd.com 1-888-823-7837

    Image of product: Perricone MD No Concealer Concealer

  • INGREDIENTS AND APPEARANCE
    NO CONCEALER CONCEALER NO.2 LIGHT TO MEDIUM 
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4062
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide48 mg  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide58.8 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    WATER (UNII: 059QF0KO0R)  
    MICA (UNII: V8A1AW0880)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
    C12-15 Alkyl Benzoate (UNII: A9EJ3J61HQ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    DEANOL (UNII: 2N6K9DRA24)  
    PEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROXYPROPYL .BETA.-CYCLODEXTRIN (UNII: 1I96OHX6EK)  
    N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
    CHRYSIN (UNII: 3CN01F5ZJ5)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4062-21 in 1 CARTON
    1NDC:62742-4062-19 g in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/26/2014
    Labeler - Allure Labs, Inc (926831603)
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