ALMAY SMART SHADE SMART BALANCE MAKE-UP- titanium dioxide zinc oxide liquid 
Almay, Inc.

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.

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Almay Smart Shade Smart Balance Make-Up

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

1

ALMAY SMART SHADE SMART BALANCE MAKE-UP 
titanium dioxide zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0311-0703
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.8 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0311-0703-0130 mL in 1 TUBE; Type 0: Not a Combination Product04/20/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/20/2009
Labeler - Almay, Inc. (064988652)
Establishment
NameAddressID/FEIBusiness Operations
REVLON, INC.809725570manufacture(0311-0703)

Revised: 12/2016
Document Id: 4431d18a-a361-0d68-e054-00144ff88e88
Set id: 44318cdb-aa87-0b09-e054-00144ff8d46c
Version: 1
Effective Time: 20161221
 
Almay, Inc.