Label: FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE COCOA- octinoxate and titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 August 16, 2013

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

  • DESCRIPTION

    Makeup that feels like your own skin, only better. Light, breathable formula smooths on seamlessly for a naturally luminous look that lasts all day. Minimizes the look of pores and imperfections immediately and over time with continued use. Hydro-pigment color technology, vitamins and antioxidants protect and perfect, so skin looks beautifully even-toned and flawless.

  • INDICATIONS & USAGE

    smooth onto face.

  • WARNINGS

    For external use only
  • OTC - ACTIVE INGREDIENT

    OCTINOXATE 4.00%..............Sunscreen

    TITANIUM DIOXIDE 1.26%....Sunscreen

  • INACTIVE INGREDIENT

    WATER/AQUA/EAU, ISOHEXADECANE, HEXYL LAURATE, MICA, GLYCERIN, POLYGLYCERYL-4 ISOSTEARATE, POTASSIUM CETYL PHOSPHATE, CETEARYL ALCOHOL, ASCORBYL PALMITATE, BETAINE, CARBOMER, GLYCERYL STEARATE, HYDROLYZED VEGETABLE PROTEIN, LECITHIN, MAGNESIUM ALUMINUM SILICATE, PEG-100 STEARATE, POLYGLYCERYL-10 MYRISTATE, SODIUM HYDROXIDE, TOCOPHERYL ACETATE, TREMELLA FUCIFORMIS SPOROCARP EXTRACT, CHLORPHENESIN, PHENOXYETHANOL, POTASSIUM SORBATE, SODIUM BENZOATE, SODIUM DEHYDROACETATE [MAY CONTAIN/PEUT CONTENIR (+/-) IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

  • OTC - DO NOT USE

    Do not

    use on damaged or broken skin

  • OTC - KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
  • OTC - PURPOSE

    Provides SPF 15 sun protection.

  • OTC - STOP USE

    Stop use and ask a doctor if rash occurs
  • OTC - WHEN USING

    keep out of eyes. Rinse with water to remove.

  • PRINCIPAL DISPLAY PANEL

    FLAWLESS FINISH PERFECTLY NUDE MAKEUP SPF 15

  • INGREDIENTS AND APPEARANCE
    FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE COCOA 
    octinoxate and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-2027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1500 mg
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE18.9 mg  in 1500 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    MICA (UNII: V8A1AW0880)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BETAINE (UNII: 3SCV180C9W)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    Product Characteristics
    ColorBROWN (BROWN) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-2027-11 in 1 BOX
    1NDC:67938-2027-21500 mg in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/17/2013
    Labeler - Elizabeth Arden, Inc (849222187)
    Establishment
    NameAddressID/FEIBusiness Operations
    Intercos883457061manufacture(67938-2027)