PURE FINISH MINERAL TINTED MOISTURIZER SPF 15- octinoxate lotion 
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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BB0906

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

Pure Finish Mineral Tinted Moisturizer Carton

Pure Finish Mineral Tinted Moistureizer Tube

PURE FINISH MINERAL TINTED MOISTURIZER SPF 15 
octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 mL  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.15 mL  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67938-110-011 in 1 BOX
1NDC:67938-110-0250 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/26/2010
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 6/2011
Document Id: aae738b0-8868-4a6a-89b9-01fbb4e7160a
Set id: f30dc513-c417-49b8-8aa9-f93fce371eb0
Version: 4
Effective Time: 20110610
 
Elizabeth Arden, Inc