Label: ALMAY SMART SHADE SMART BALANCE MAKE-UP- titanium dioxide zinc oxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0311-0703-01 - Packager: Almay, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 21, 2016
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- Active Ingredients:
- Purpose
- Uses:
- Warnings:
- Directions
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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 value of 15 or higher and other sun protection measures including:
•Limit time in the sun, especially from 10 am - 2 pm
•Wear long-sleeved shirts, pants, hats and sunglasses. -
Inactive Ingredients
Aqua ((Water) Eau), Cyclopentasiloxane, Cyclohexasiloxane, Dimethicone, Butylene Glycol, HDI/Trimethylol Hexyllactone Crosspolymer, Nylon-12, Cetyl PEG/PPG-10/1 Dimethicone, PEG/PPG-18/18 Dimethicone, Talc, Disteardimonium Hectorite, Alumina, Sodium Chloride, Sodium Hyaluronate, Fomes Officinalis (Mushroom) Extract, Glycerin, Hydrolyzed Glycosaminoglycans, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Extract, Centaurea Cyanus Flower Extract, Camellia Sinensis Leaf Extract, Panax Ginseng Root Extract, Ginkgo Biloba Leaf Extract, Aspalathus Linearis Leaf Extract, Hydrogenated Lecithin, Trisiloxane, Moringa Pterygosperma Seed Extract, Trimethylsiloxysilicate, Triethoxycaprylylsilane, Galactoarabinan, Acrylonitrile/Methacrylonitrile/Methyl Methacrylate Copolymer, Methoxy Amodimethicone/Silsesquioxane Copolymer, Palmitoyl Hydroxypropyltrimonium Amylopectin/ Glycerin Crosspolymer, Boron Nitride, Sorbitol, Alcohol Denat., Methicone, Tribehenin, Sorbitan Sesquioleate, Silica, Ammonium Polyacryloyldimethyl Taurate, Cycloheptasiloxane, Tetrasodium EDTA, PVP, Polysorbate 20, Polysorbate 80, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben
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INGREDIENTS AND APPEARANCE
ALMAY SMART SHADE SMART BALANCE MAKE-UP
titanium dioxide zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0311-0703 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.8 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) BORON NITRIDE (UNII: 2U4T60A6YD) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GINKGO (UNII: 19FUJ2C58T) ASIAN GINSENG (UNII: CUQ3A77YXI) CENTAUREA CYANUS FLOWER (UNII: QZ239038YC) VITIS VINIFERA SEED (UNII: C34U15ICXA) MORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) EDETATE SODIUM (UNII: MP1J8420LU) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) NYLON-12 (UNII: 446U8J075B) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) TALC (UNII: 7SEV7J4R1U) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GLYCERIN (UNII: PDC6A3C0OX) HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV) ALOE VERA LEAF (UNII: ZY81Z83H0X) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) TRISILOXANE (UNII: 9G1ZW13R0G) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) GALACTOARABINAN (UNII: SL4SX1O487) SORBITOL (UNII: 506T60A25R) ALCOHOL (UNII: 3K9958V90M) METHICONE (20 CST) (UNII: 6777U11MKT) TRIBEHENIN (UNII: 8OC9U7TQZ0) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CYCLOMETHICONE 7 (UNII: KCK5L8VU47) PVP/VA COPOLYMER (UNII: D9C330MD8B) POLYSORBATE 20 (UNII: 7T1F30V5YH) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0311-0703-01 30 mL in 1 TUBE; Type 0: Not a Combination Product 04/20/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/20/2009 Labeler - Almay, Inc. (064988652) Establishment Name Address ID/FEI Business Operations REVLON, INC. 809725570 manufacture(0311-0703)
