Label: NO CONCEALER CONCEALER- 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 December 9, 2013

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

  • ACTIVE INGREDIENT

    Active Ingredients:

    Titanium Dioxide 4.8%

    Zinc Oxide 5.88%

  • PURPOSE

    PURPOSE:

    Sunscreen

  • INDICATIONS & USAGE

    Uses:

    • Helps prevent sunburn
  • 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 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 dispensing one pump, warmimg between ring fingers and patting gently along the lower eye contours, as well as upper eye lid and inner contours of eyes if desired. Any excess can also be applied on targeted areas of the face to cover imperfections.Apply generously and evenly 15 minutes before sun exposureUse a water resistant sunscreen if swimming or sweatingReapply atleast every two hoursNot for use on children

  • STORAGE AND HANDLING

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

  • INACTIVE INGREDIENT

    Aluminum Hydroxide, Butylene Glycol, C12-15 Alkyl benzoate, Caprylyl Glyohol, Ceramide 2, Cetearyl Olivate, Cetyl PEG/PPG-10/1 Dimethicone, Chrysin, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethyl MEA, Ethylhexylglycerin, Glucosyl Herperidin, Glycerin, Hexyl Laurate, Hexylene Glyol, Hyaluronic Acid, Hydroxypropyl Cyclodextrin, Hydoxysuccinimde, Iron Oxides, Linoleamidopropyl PG-Dimonium Chloride Phophate, Mica, Nylon-12, Palmitoyl Oligopeptide, Palmitoyl Terapeptide-7, Palmitoyl Tripeptide-38, PEG/18/18 Dimethicone, PEG-10 Rapeseed Sterol, Phenoxyethanol, Polyglyceryl-3 Polydimethylsiloxyehtyl Dimethicone, Polyglyceryl-4, Isostearate, PPG-12/SMDI Copoloymer, Propylene Glycol, Silica, Silica Dimehtyl Silylate, Sodium PCA, Sorbiana Olivate, Streareth-20, Stearic Acid, Tetrahexyldecy Ascorbate, Titanium Dioxide, Tocopheryl Acetate, Tribehenin, Triethoxycaprylysilane, Triethoxylsilylethyl Polydimehtylsiloxyehtyl Hexyl Dimethicone, Water.

  • PRINCIPAL DISPLAY PANEL

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

    Distributed By (UK): NV Perricone MD Cosmeceuticals Ltd London W1S 2YE UK

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

    Image of product: Perricone MD No Concealer Concealer

  • INGREDIENTS AND APPEARANCE
    NO CONCEALER CONCEALER 
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4059
    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
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
    CHRYSIN (UNII: 3CN01F5ZJ5)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DEANOL (UNII: 2N6K9DRA24)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSYL HESPERIDIN (UNII: 432C95B6YE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    HYDROXYPROPYL .BETA.-CYCLODEXTRIN (UNII: 1I96OHX6EK)  
    N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)  
    MICA (UNII: V8A1AW0880)  
    NYLON-12 (UNII: 446U8J075B)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    PEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4059-21 in 1 CARTON
    1NDC:62742-4059-19 g in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/09/2013
    Labeler - Allure Labs, Inc (926831603)