ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20- titanium dioxide, zinc oxide liquid

ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 by

Drug Labeling and Warnings

ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 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: 5.5%

Zinc Oxide 2.4%

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

CYCLOPENTASILOXANE, AQUA ((WATER) EAU), DIMETHICONE, PHENYL TRIMETHICONE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIMETHYLSILOXYSILICATE, BUTYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, SILICA, NYLON-12, TRIBEHENIN, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ALUMINA, TOCOPHERYL ACETATE, NIACINAMIDE, PISUM SATIVUM (PEA) EXTRACT, GLYCINE SOJA (SOYBEAN) OIL, HYDROLYZED RICE PROTEIN, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED EXTRACT, LAMINARIA JAPONICA EXTRACT, NEREOCYSTIS LUETKEANA EXTRACT, MACROCYSTIS PYRIFERA (KELP) EXTRACT, SACCHAROMYCES/MAGNESIUM FERMENT, SACCHAROMYCES/POTASSIUM FERMENT, PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER, SODIUM HYALURONATE, OLIGOPEPTIDE-24, GLYCERIN, PALMITOYL TRIPEPTIDE-5, MELANIN, POLYESTER-1, LAURETH-7, MAGNESIUM SULFATE, POLYGLYCERYL-3 DIISOSTEARATE, METHICONE, TRIETHOXYCAPRYLYLSILANE, POLYSILICONE-11, DISTEARDIMONIUM HECTORITE, ETHYLENE BRASSYLATE, SILICA DIMETHYL SILYLATE, TRIETHYL CITRATE, TETRASODIUM EDTA, DIPROPYLENE GLYCOL, SODIUM CITRATE, TOCOPHEROL, PENTYLENE GLYCOL, MALTODEXTRIN, SUCROSE DILAURATE, SODIUM COCOYL GLUTAMATE, PHENOXYETHANOL, ETHYLPARABEN, METHYLPARABEN

Principal Display Panel

Almay

ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20

1 oz/ 30mL

INGREDIENTS AND APPEARANCE

ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 
titanium dioxide, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0311-0710
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.4 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NYLON-12 (UNII: 446U8J075B)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
NIACINAMIDE (UNII: 25X51I8RD4)
PEA (UNII: W4X7H8GYFM)
SOYBEAN (UNII: L7HT8F1ZOD)
ALMOND (UNII: 3Z252A2K9G)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
LAURETH-7 (UNII: Z95S6G8201)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POLYSILICONE-15 (UNII: F8DRP5BB29)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
EDETATE SODIUM (UNII: MP1J8420LU)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCROSE DILAURATE (UNII: 5926LC4S7M)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
LAMINARIA JAPONICA (UNII: WE98HW412B)
NEREOCYSTIS LUETKEANA (UNII: 3PC632V63J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0311-0710-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	04/16/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/16/2016

Labeler - Almay, Inc. (064988652)

Establishment
Name	Address	ID/FEI	Business Operations
REVLON, INC.		809725570	manufacture(0311-0710)