PURE FINISH MINERAL POWDER FOUNDATION SPF 20 PURE FINISH 5- titanium dioxide powder

Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 5 by

Drug Labeling and Warnings

Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 5 by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PURE FINISH MINERAL POWDER FOUNDATION SPF 20 PURE FINISH 5 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-1394
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.358 g  in 8.33 g

Inactive Ingredients
Ingredient Name	Strength
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)

Product Characteristics
Color	PINK (Pure Finish 5)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-1394-1	1 in 1 BOX
1	NDC: 67938-1394-2	8.33 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/20/2010

Labeler - Elizabeth Arden, Inc (849222187)