Label: FLAWLESS FINISH BARE PERFECTION MAKEUP SPF 8 PERFECT BEIGE- octinoxate lotion

  • Category: HUMAN OTC DRUG LABEL

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 May 6, 2011

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • DESCRIPTION

    For normal skin. Medium coverage. Natural finish. This oil free liquid makeup gives skin a firmer look and reflects light to soften fine lines. SPF 8 provides sun protection. Clinically, dermatologist and allergy tested.

  • INDICATIONS AND USAGE

    To Use: Smooth on to face before sun exposure.

  • WARNINGS

    Warning: For external use only. Keep out of eyes.Stop use and see a doctor is rash or irritation develops and lasts. Keep out of reach of children.

  • OTC - ACTIVE INGREDIENT

    Active Ingredient: Octinoxate 4.0% w/w.

  • INACTIVE INGREDIENT

    Other Ingredients: Water/Aqua/Eau, Isostearyl Palmitate, C12-15 Alkyl Benzoate, Butylene Glycol, Dimethicone, Oleic Acid, Glycerin, C12-20 Acid PEG-8 Ester, Polysorbate 40, Triethanolamine, Magnesium Aluminum Silicate, Dimethicone Copolyol, Phenyl Trimethicone, Sodium Hyaluronate, Retinyl Linoleate, Tocopherol, Glyceryl Stearate SE, Sucrose Laurate, Trehalose, Lecithin, Phospholipids, Tridecyl Salicylate, Decyl Glucoside, PEG-40 Stearate, Sorbitan Palmitate, Sorbitan Stearate, Behenyl Alcohol, Carbomer, Xanthan Gum, Disodium EDTA, Kaolin, Silica, Cyclopentasiloxane, Dimethiconol, Parfum/Fragrance, Butylphenyl Methylpropional, Hydroxycitronellal, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Propylparaben, Iron Oxides (CI77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).

  • DOSAGE & ADMINISTRATION

    Smooth on to face.

  • OTC - KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTC - PURPOSE

    SPF 8 provides sun protection.

  • OTC - WHEN USING

    Keep out of eyes.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Flawless Finish Bare Perfection Makeup Carton

  • INGREDIENTS AND APPEARANCE
    FLAWLESS FINISH BARE PERFECTION MAKEUP SPF 8 PERFECT BEIGE 
    octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0860
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.1988 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 40 (UNII: STI11B5A2X)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    KAOLIN (UNII: 24H4NWX5CO)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SUCROSE LAURATE (UNII: 05Q7CD0E49)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
    Product Characteristics
    ColorPINK (Perfect Beige) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-0860-11 in 1 BOX
    1NDC:67938-0860-230 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/06/2011
    Labeler - Elizabeth Arden, Inc (849222187)