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Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 1

Dosage form: powder
Ingredients: TITANIUM DIOXIDE 0.358g in 8.33g
Labeler: Elizabeth Arden, Inc
NDC Code: 67938-1390

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.

BP1390

DESCRIPTION

For all skin types. Mediun/full coverage. Pure, luminous finish. Pure minerals. Pure comfort. Pure perfection. This microlight mineral makeup is ultra blendable and buildable. SPF 20 sun protection. Fragrance free. Talc free. Oil free. Freshly ground for ultimate purity. Clinically and dermatologist tested. Sensititve skin tested.

INDICATIONS AND USAGE

To Use: Turn dial to the right to release product. Smooth on to face before sun exposure.

WARNINGS

WARNING: For extrenal use only. Keep out of eyes. Stop use and see a doctor if rash or irritation develops and lasts.

OTC - ACTIVE INGREDIENT

Active Ingredient: Titanium Dioxide 4.31% w/w.

INACTIVE INGREDIENT

Other Ingredients: Mica, Dimethicon, Nylon-12, Zinc Stearate, Silica, Methicon, Squalane, Magnesium Myristate, Sea Salt/Maris Sal/Sel Marin, Aloe Barbadensis Leaf Jucie, Silk Powder/Serica/Poudre de Soice, Ascorbyl Palmitate, Retinyl Palmitate, Tocopherol, Alumina, Oryza Sative (Rice) Starch, Butylparaben, Methylparaben, Propylparaben, Sodium Dehydroacetate. [May Contain/Peut Contenir (+/-) Bismuth Oxychloride (CI 77163), Carmine (CI 75470), Iron Oxides (CI 77491, 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

Provides SPF 20 sun protection.

OTC - WHEN USING

Keep out of eyes.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL



PURE FINISH MINERAL POWDER FOUNDATION SPF 20 PURE FINISH 1 
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1390
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.358 g  in 8.33 g
Inactive Ingredients
Ingredient NameStrength
MICA 
DIMETHICONE 
ZINC STEARATE 
SILICON DIOXIDE 
SQUALANE 
MAGNESIUM MYRISTATE 
SEA SALT 
STARCH, RICE 
ALUMINUM OXIDE 
METHYLPARABEN 
SODIUM DEHYDROACETATE 
ALOE VERA LEAF 
PROPYLPARABEN 
VITAMIN A PALMITATE 
ASCORBYL PALMITATE 
BUTYLPARABEN 
ALPHA-TOCOPHEROL 
Product Characteristics
ColorPINK (Pure Finish 1) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:67938-1390-11 CONTAINER (1 CONTAINER) in 1 BOX
1NDC:67938-1390-28.33 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/20/2010
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 01/2011
Document Id: ad45ffb5-5db6-4712-856a-8b2d9b495d67
Set id: 4d36e6a7-a0a9-4b51-b5d8-4c22d2fbcc6f
Version: 3
Effective Time: 20110111
 
Elizabeth Arden, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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