PURE FINISH MINERAL POWDER FOUNDATION SPF 20- titanium dioxide 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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BT0102

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.

Pure Finish Mineral Powder Foundation Carton

Pure Finish Mineral Powder Foundation SPF 20 Base Label


PURE FINISH MINERAL POWDER FOUNDATION SPF 20 
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.358 g  in 8.33 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC STEARATE (UNII: H92E6QA4FV)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SQUALANE (UNII: GW89575KF9)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
SEA SALT (UNII: 87GE52P74G)  
STARCH, RICE (UNII: 4DGK8B7I3S)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67938-102-011 in 1 BOX
1NDC:67938-102-028.33 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: 1/2011
Document Id: 9dff3920-a9a8-4071-9ed2-d96ebae108bd
Set id: e2a3d9ed-5d05-41a3-90ca-ea5df6d5d713
Version: 4
Effective Time: 20110111
 
Elizabeth Arden, Inc