INTERVENE MAKEUP SPF 15 SOFT TOFFEE - octinoxate cream 
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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DESCRIPTION

For normal skin. Medium/full coverage. Soft natural finish. This innovative liquid makeup with Biodormin technology helps delay the appearance of new lines and wrinkles as it firms the look of skin. Micro-mineral pigment technology smoothes imperfections, evens out skin tone and creates a soft natural finish that lasts all day. Provides SPF 15 sun protection. Clinitcally, dermatologist, and allergy tested.

INDICATIONS AND USAGE

To Use: Smooth on to face before sun exposure.

WARNINGS

Warning: For external use only. Keep out of eyes. Stop use and see a doctor if rash or irritation develops and lasts. Keep out of reach of children.

OTC - ACTIVE INGREDIENT

Active Ingredient: Octinoxate 5% w/w.

INACTIVE INGREDIENT

Other Ingredients: Cyclopentasiloxane, Water/Aqua/Eau, Isododecane, Butylene Glycol, Ethylhexyl Methoxycinnamate, Talc, Mica, Polymethyl Methacrylate, Silica Silylate, Sorbitan Tristearate, PEG/PPG-18/18 Dimethicone, Silica, Trimethylsiloxysilicate, Palmitoyl Tetrapeptide-7, Narcissus Tazetta Bulb Extract, Trifolium Pratense (Clover) Flower Extract, Ascorbyl Plamitate, Tocopherol, Lecithin, Clycerin, Hydolyzed Soy Protein, Laureth-4, Laureth-7, Steareth-20, Disteardimonium Hectorite, Deimethicone/Vinyl Dimethicone Crosspolymer, Propylene Carbonate, BHT, Sodium Chloride, Dimethicone, Dimethiconol, Fragrance/Parfum, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Propylparaben, Sodium Dehydroacetate, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI77891).

DOSAGE & ADMINISTRATION

Smooth on to face.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTC - PURPOSE

Provides SPF 15 sun protection.

OTC - WHEN USING

Keep out of eyes.

Intervene Makeup Carton


INTERVENE MAKEUP SPF 15 SOFT TOFFEE 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1088
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE1.5 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER7.2 mL  in 30 mL
ISODODECANE2.82 mL  in 30 mL
BUTYLENE GLYCOL1.53 mL  in 30 mL
TALC1.2 mL  in 30 mL
SORBITAN TRISTEARATE0.6 mL  in 30 mL
SILICON DIOXIDE0.3 mL  in 30 mL
MICA0.28 mL  in 30 mL
PHENOXYETHANOL0.22 mL  in 30 mL
DIMETHICONE0.17 mL  in 30 mL
SODIUM CHLORIDE0.075 mL  in 30 mL
GLYCERIN0.072 mL  in 30 mL
PROPYLENE CARBONATE0.06 mL  in 30 mL
LAURETH-70.06 mL  in 30 mL
SODIUM DEHYDROACETATE0.06 mL  in 30 mL
METHYLPARABEN0.048 mL  in 30 mL
ETHYLPARABEN0.012 mL  in 30 mL
BUTYLPARABEN0.012 mL  in 30 mL
NARCISSUS TAZETTA BULB0.012 mL  in 30 mL
PROPYLPARABEN0.006 mL  in 30 mL
ISOBUTYLPARABEN0.006 mL  in 30 mL
LAURETH-40.006 mL  in 30 mL
ALPHA-TOCOPHEROL0.003 mL  in 30 mL
ASCORBYL PALMITATE0.003 mL  in 30 mL
STEARETH-200.002 mL  in 30 mL
BUTYLATED HYDROXYTOLUENE0.0016 mL  in 30 mL
TRIFOLIUM PRATENSE FLOWER0.0004 mL  in 30 mL
PALMITOYL TETRAPEPTIDE-73e-005 mL  in 30 mL
Product Characteristics
ColorBROWN (Soft Toffee) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:67938-1088-11 BOTTLE, PUMP (1 BOTTLE) in 1 BOXcontains a BOTTLE, PUMP (67938-1088-2)
1NDC:67938-1088-230 mL in 1 BOTTLE, PUMPThis package is contained within the BOX (67938-1088-1)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/06/2010

Labeler - Elizabeth Arden, Inc (849222187)
Establishment
NameAddressID/FEIOperations
Intercos883457061manufacture

Revised: 01/2011 Elizabeth Arden, Inc