Pure Finish Mineral Tinted Moisturizer Spf 15 (Octinoxate) Lotion [Elizabeth Arden, Inc] -

PURE FINISH MINERAL TINTED MOISTURIZER SPF 15 (OCTINOXATE) LOTION [ELIZABETH ARDEN, INC]
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NDC	67938-110-01, 67938-110-02
Set ID	f30dc513-c417-49b8-8aa9-f93fce371eb0
Category	HUMAN OTC DRUG LABEL
Packager	Elizabeth Arden, Inc
Generic Name
Product Class
Product Number
Application Number	PART352

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DESCRIPTION

For all skin types. Sheer, natural coverage. Pure, radiant finish. Pure minerals. Pure comfort. Pure perfection. This microlight mineral tinted moisturizer, infused with minerals, vitamins, and antioxidants brightens and evens out skintone with a hint of sheer, natural color. Instantly transforms skin's appearance with a fresh, luminous glow. SPF 15 sun protection. Oil free. Talc free. Fragrance free.
INDICATIONS AND USAGE

To Use: Smooth on to face before sun exposure.
WARNINGS

WARNING: For external use only. Avoid contact with eyes. Discontinue use if irritation or rash appear. If irritation persists, consult a doctor. Keep out of reach of children. Clinically, dermatologist, and allergy tested.
OTC - ACTIVE INGREDIENT

Active Ingredients: Octinoxate 6.0%, Titanium Dioxide 4.3%, Octisalate 4.0%.
INACTIVE INGREDIENT

Other Ingredients: Water/Aqua/Eau, Dimethicone, Mica, Cetearyl Alcohol, Polyglyceryl-4 Isostearate, Cetyl Dimethicon, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicon, Sodium Stearoyl Lactylate, Squalane, Hydrogenated Polyisobutene, Silene Uniflora Extract, Sodium Hyaluronate, Retinyl Palmitate, Tetrahexyldecyl Ascrobate, Tocopherol, Tocopheryl Acetate, Jojoba Esters, Glycerin, Triethoxycaprylylsilane, Carbomer, Magnesium Aluminum Silicate, Triethanolamine, Trisodium EDTA, Methyparaben, Phenoxyethanol, Propylparaben, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI77891).
DOSAGE & ADMINISTRATION

Smooth on to face.
OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
OTC - PURPOSE

Provides SPF 15 sun protection.
OTC - WHEN USING

Avoid contact with eyes.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURE FINISH MINERAL TINTED MOISTURIZER SPF 15
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67938-110
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3 mL in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.15 mL in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 mL in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
SQUALANE (UNII: GW89575KF9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
METHYLPARABEN (UNII: A2I8C7HI9T)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE TRISODIUM (UNII: 420IP921MB)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)

#	Item Code	Package Description
Packaging
1	NDC:67938-110-01	1 in 1 BOX
1	NDC:67938-110-02	50 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	07/26/2010

Labeler - Elizabeth Arden, Inc (849222187)

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Medic

PURE FINISH MINERAL TINTED MOISTURIZER SPF 15 (OCTINOXATE) LOTION [ELIZABETH ARDEN, INC]

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