INTERVENE MAKEUP SPF 15 SOFT WHEAT- 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.

----------

BC1082

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Intervene Makeup Carton

INTERVENE MAKEUP SPF 15 SOFT WHEAT 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1082
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.5 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TALC (UNII: 7SEV7J4R1U)  
SORBITAN TRISTEARATE (UNII: 6LUM696811)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
LAURETH-7 (UNII: Z95S6G8201)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
NARCISSUS TAZETTA BULB (UNII: K17762966S)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
LAURETH-4 (UNII: 6HQ855798J)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
STEARETH-20 (UNII: L0Q8IK9E08)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
Product Characteristics
ColorBROWN (Soft Wheat) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67938-1082-11 in 1 BOX
1NDC:67938-1082-230 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/06/2010
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 1/2011
Document Id: 87348e8c-b0bf-4f0a-a6b6-9b699b60ce10
Set id: 488a22b2-1b9e-4d26-b7e4-6a438dae7ca2
Version: 3
Effective Time: 20110113
 
Elizabeth Arden, Inc