Label: FLAWLESS FINISH DUAL PERFECTION MAKEUP SPF 8 SHELL- titanium dioxide powder

  • 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 January 13, 2011

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  • DESCRIPTION

    For normal to oily skin. Adjustable coverage. Matte finish. Ultra fine powder and foundation in one. Wet it's a soft matte makeup. Dry it's a perfectly matte makeup or finishing powder. Ideal for touch-ups. 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 Ingredients: Titanium Dioxide 7.0% w/w, Octinoxate 3.6% w/w.

  • INACTIVE INGREDIENT

    Other Ingredients: Talc, Zinc Stearate, Nylon-12, Dimethicone, Ethylhexyl Palmitate, Pentaerythrityl Tetraethylhexanoate, Methicone, Aluminum Hydroxide, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Propylparaben, Iron Oxides, Mica, Titanium Dioxide.

  • 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 Dual Perfection Makeup Carton

  • INGREDIENTS AND APPEARANCE
    FLAWLESS FINISH DUAL PERFECTION MAKEUP SPF 8 SHELL 
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1163
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.19 g  in 17 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.59 g  in 17 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    MICA (UNII: V8A1AW0880)  
    OCTINOXATE (UNII: 4Y5P7MUD51)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    ColorPINK (Shell) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-1163-11 in 1 BOX
    1NDC:67938-1163-217 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/24/2006
    Labeler - Elizabeth Arden, Inc (849222187)
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