Pure Finish Mineral Tinted Moisturizer SPF 15 Fair

Dosage form: lotion
Ingredients: OCTINOXATE 3mL in 50mL, TITANIUM DIOXIDE 2.15mL in 50mL, OCTISALATE 2mL in 50mL
Labeler: Elizabeth Arden, Inc
NDC Code: 67938-0906

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.

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.

PURE FINISH MINERAL TINTED MOISTURIZER SPF 15 FAIR 
octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0906
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE3 mL  in 50 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE2.15 mL  in 50 mL
OCTISALATE (OCTISALATE) OCTISALATE2 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIMETHICONE 
CETOSTEARYL ALCOHOL 
POLYGLYCERYL-4 ISOSTEARATE 
HEXYL LAURATE 
SODIUM STEAROYL LACTYLATE 
SQUALANE 
PHENOXYETHANOL 
MICA 
METHYLPARABEN 
TROLAMINE 
GLYCERIN 
MAGNESIUM ALUMINUM SILICATE 
PROPYLPARABEN 
EDETATE TRISODIUM 
VITAMIN A PALMITATE 
TETRAHEXYLDECYL ASCORBATE 
TRIETHOXYCAPRYLYLSILANE 
HYALURONATE SODIUM 
ALPHA-TOCOPHEROL 
Product Characteristics
ColorPINK (Fair) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:67938-0906-11 TUBE (1 TUBE) in 1 BOX
1NDC:67938-0906-250 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: 06/2011
 
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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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