Label: INTERVENE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SOFT CAMEO- octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 67938-1079-1, 67938-1079-2, 67938-1079-3 - Packager: Elizabeth Arden, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 11, 2013
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- Official Label (Printer Friendly)
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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 smooths imperfections, evens out skin tone and creates a soft natural finish that lasts all day.
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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
- OTC - ACTIVE INGREDIENT
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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
- KEEP OUT OF REACH OF CHILDREN
- OTC - PURPOSE
- OTC - WHEN USING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INTERVENE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SOFT CAMEO
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-1079 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.5 g in 30 g 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 Cameo) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67938-1079-1 1 in 1 BOX 1 NDC:67938-1079-2 30 g in 1 BOTTLE, PUMP 2 NDC:67938-1079-3 25000 g in 1 PAIL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/06/2010 Labeler - Elizabeth Arden, Inc (849222187)
