FLAWLESS FINISH DUAL PERFECTION MAKEUP SPF 8 SHELL - titanium dioxide and octinoxate powder 
Elizabeth Arden, Inc

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.

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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


FLAWLESS FINISH DUAL PERFECTION MAKEUP SPF 8 SHELL 
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1163
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE1.19 g  in 17 g
OCTINOXATE (OCTINOXATE) OCTINOXATE0.59 g  in 17 g
Inactive Ingredients
Ingredient NameStrength
TALC10.81 g  in 17 g
MICA0.85 g  in 17 g
OCTINOXATE0.595 g  in 17 g
ZINC STEARATE0.306 g  in 17 g
STEARIC ACID0.253 g  in 17 g
DIMETHICONE0.144 g  in 17 g
ETHYLHEXYL PALMITATE0.122 g  in 17 g
ALUMINUM HYDROXIDE0.09 g  in 17 g
PHENOXYETHANOL0.06 g  in 17 g
METHYLPARABEN0.034 g  in 17 g
BUTYLPARABEN0.0051 g  in 17 g
ETHYLPARABEN0.0034 g  in 17 g
PROPYLPARABEN0.0017 g  in 17 g
Product Characteristics
ColorPINK (Shell) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:67938-1163-11 CONTAINER (1 CONTAINER) in 1 BOXcontains a CONTAINER (67938-1163-2)
1NDC:67938-1163-217 g in 1 CONTAINERThis package is contained within the BOX (67938-1163-1)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/24/2006

Labeler - Elizabeth Arden, Inc (849222187)
Establishment
NameAddressID/FEIOperations
CEI032565959manufacture

Revised: 01/2011 Elizabeth Arden, Inc