Label: NO MAKEUP CONCEALER (DEEP) SPF 20- zinc oxide emulsion

  • 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 July 10, 2023

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  • DOSAGE & ADMINISTRATION

    Dosage Administration

  • INACTIVE INGREDIENT

    Inactive Ingredient

  • INDICATIONS & USAGE

    Indications Usage

  • ACTIVE INGREDIENT

    OTC Active Ingredient Section

  • KEEP OUT OF REACH OF CHILDREN

    OTC keep out of reach of children

  • PURPOSE

    OTC Purpose Section

  • PRINCIPAL DISPLAY PANEL

    package Label Principle Display Panel

  • INGREDIENTS AND APPEARANCE
    NO MAKEUP CONCEALER (DEEP) SPF 20 
    zinc oxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45634-733
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.7434 g  in 9 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)  
    POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIHEPTANOIN (UNII: 2P6O7CFW5K)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    C13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STANNOUS OXIDE (UNII: JB2MV9I3LS)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    DARUTOSIDE (UNII: EG8ODI0780)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    NYLON-12 (UNII: 446U8J075B)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Product Characteristics
    Colorbrown (Skin Tone Colours) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45634-733-9310 g in 1 BOTTLE; Type 0: Not a Combination Product04/26/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/26/2022
    Labeler - N.V. Perricone LLC (054414243)