ALMAY SMART SHADE SMART BALANCE MAKE-UP- titanium dioxide zinc oxide liquid

Almay Smart Shade Smart Balance Make-Up by

Drug Labeling and Warnings

Almay Smart Shade Smart Balance Make-Up by is a Otc medication manufactured, distributed, or labeled by Almay, Inc., REVLON, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Titanium Dioxide: 3.8%

Zinc Oxide 2.0%

Purpose

Sunscreen

Uses:

Helps prevent sunburn
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings:

For external use only
Do notuse 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 a rash occurs
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control center right away

Directions

Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Children under 6 months: Ask a doctor.

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

Principal Display Panel

Almay

Almay Smart Shade Smart Balance Make-Up

INGREDIENTS AND APPEARANCE

ALMAY SMART SHADE SMART BALANCE MAKE-UP 
titanium dioxide zinc oxide liquid

Product 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)