ALMAY SMART SHADE SKINTONE ANTI- AGING MAKE-UP- titanium dioxide zinc oxide liquid

Almay Smart Shade Skintone Anti- Aging Make-Up by

Drug Labeling and Warnings

Almay Smart Shade Skintone Anti- Aging 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: 3.9%

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), Dimethicone, Isododecane, Trisiloxane, Butylene Glycol, PEG/PPG-19/19 Dimethicone, C13-16 Isoparaffin, HDI/Trimethylol Hexyllactone Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Nylon-12, Sodium Chloride, Phenyl Trimethicone, Alumina, Glycerin, Melanin, Palmitoyl Tripeptide-5, Oligopeptide-24, Sodium Cocoyl Glutamate, Saccharomyces Magnesium Ferment, Saccharomyces Potassium Ferment, Pisum Sativum (Pea) Extract, Macrocystis Pyrifera Extract, Nereocystis Leutkeana Extract, Laminaria Japonica Extract, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, Hydrolyzed Rice Protein, Sodium Hyaluronate, Palmitoyl Hydroxypropyltrimonium Amylopectin/Glycerin Crosspolymer, Hydrogenated Lecithin, Pentylene Glycol, Isodecyl Neopentanoate, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Galactoarabinan, Trimethylsiloxysilicate, Boron Nitride, Disteardimonium Hectorite, Polyisobutene, C10-13 Isoparaffin, Methicone, Triethoxycaprylylsilane, Tribehenin, Tocopheryl Acetate, Tocopherol, Propylene Carbonate, Silica, Sorbitan Sesquioleate, Maltodextrin, Sucrose Dilaurate, Acrylonitrile/Methacrylonitrile/Methyl Methacrylate Copolymer, Phenoxyethanol, Tetrasodium EDTA, Caprylyl Glycol, 1, 2-Hexanediol

Principal Display Panel

Almay

Skintone Matching Anti Aging  Makeup

1 oz/ 30mL

INGREDIENTS AND APPEARANCE

ALMAY SMART SHADE SKINTONE ANTI- AGING MAKE-UP 
titanium dioxide zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0311-0702
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
DIMETHICONE (UNII: 92RU3N3Y1O)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISODODECANE (UNII: A8289P68Y2)
TRISILOXANE (UNII: 9G1ZW13R0G)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
NYLON-12 (UNII: 446U8J075B)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
GALACTOARABINAN (UNII: SL4SX1O487)
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)
BORON NITRIDE (UNII: 2U4T60A6YD)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
SUCROSE DILAURATE (UNII: 5926LC4S7M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PEA (UNII: W4X7H8GYFM)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
NEREOCYSTIS LUETKEANA (UNII: 3PC632V63J)
LAMINARIA JAPONICA (UNII: WE98HW412B)
ALMOND (UNII: 3Z252A2K9G)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0311-0702-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	11/14/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/14/2013

Labeler - Almay, Inc. (064988652)

Establishment
Name	Address	ID/FEI	Business Operations
REVLON, INC.		809725570	manufacture(0311-0702)