Intervene Makeup Broad Spectrum Sunscreen SPF 15 Soft Cream

Dosage form: cream
Ingredients: OCTINOXATE 1.5g in 30g
Labeler: Elizabeth Arden, Inc
NDC Code: 67938-1077

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.

BC1077

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 smooths imperfections, evens out skin tone and creates a soft natural finish that lasts all day.

INDICATIONS AND USAGE

To Use: Smooth on to face.

Directions For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply: at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.

WARNINGS

Warnings:

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

OTC - ACTIVE INGREDIENT

Active Ingredient: Octinoxate 5.0%.

INACTIVE INGREDIENT

Other Ingredients: Cyclopentasiloxane, Water/Aqua/Eau, Isododecane, Butylene Glycol, 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. If product is swallowed, get medical help or contact a Poison Control Center right away.

OTC - PURPOSE

Provides SPF 15 Sun Protection.

OTC - WHEN USING

Keep out of eyes.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


INTERVENE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SOFT CREAM 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1077
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE1.5 g  in 30 g
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
ColorPINK (Soft Cream) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:67938-1077-11 BOTTLE, PUMP in 1 BOX
1NDC:67938-1077-230 g in 1 BOTTLE, PUMP
2NDC:67938-1077-325000 g in 1 PAIL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/06/2010
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 07/2013
 
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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