Intervene Makeup SPF 15 Soft Wheat

Dosage form: cream
Ingredients: OCTINOXATE 1.5mL in 30mL
Labeler: Elizabeth Arden, Inc
NDC Code: 67938-1082

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 SPF 15 SOFT WHEAT 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1082
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE1.5 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ISODODECANE 
BUTYLENE GLYCOL 
TALC 
SORBITAN TRISTEARATE 
SILICON DIOXIDE 
MICA 
PHENOXYETHANOL 
DIMETHICONE 
SODIUM CHLORIDE 
GLYCERIN 
PROPYLENE CARBONATE 
LAURETH-7 
SODIUM DEHYDROACETATE 
METHYLPARABEN 
ETHYLPARABEN 
BUTYLPARABEN 
NARCISSUS TAZETTA BULB 
PROPYLPARABEN 
ISOBUTYLPARABEN 
LAURETH-4 
ALPHA-TOCOPHEROL 
ASCORBYL PALMITATE 
STEARETH-20 
BUTYLATED HYDROXYTOLUENE 
TRIFOLIUM PRATENSE FLOWER 
PALMITOYL TETRAPEPTIDE-7 
Product Characteristics
ColorBROWN (Soft Wheat) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:67938-1082-11 BOTTLE, PUMP (1 BOTTLE) 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: 01/2011
 
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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