INTERVENE MAKEUP SPF 15 SOFT PORCELAIN- octinoxate cream

Intervene Makeup SPF 15 Soft Porcelain by

Drug Labeling and Warnings

Intervene Makeup SPF 15 Soft Porcelain by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

INTERVENE MAKEUP SPF 15 SOFT PORCELAIN 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-1074
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.5 mL  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	PINK (Soft Porcelain)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-1074-1	1 in 1 BOX
1	NDC: 67938-1074-2	30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/06/2010

Labeler - Elizabeth Arden, Inc (849222187)