ALMAY AGE SMART SHADE CC LUMINOUS PRIMER SPF 15- zinc oxide, titanium dioxide make-up liquid

Almay Age Smart Shade CC Luminous Primer SPF 15 by

Drug Labeling and Warnings

Almay Age Smart Shade CC Luminous Primer SPF 15 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:

Zinc Oxide: 3.3%

Titanium Dioxide 4.3%

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, Dimethicone, Phenyl Trimethicone, PEG-9 Polydimethylsiloxyethyl Dimethicone, Glycerin, Boron Nitride, Adipic Acid/Neopentyl Glycol Crosspolymer, Trimethylsiloxysilicate, Butylene Glycol, Disteardimonium Hectorite, Dimethicone/PEG-10/15 Crosspolymer, Alumina, Dimethicone Crosspolymer, Methyl Acetylglycyrrhetinoyl Hydroxyprolinate, Thermus Thermophillus Ferment, Alpha-Glucan Oligosaccharide, Polymnia Sonchifolia Root Juice, Tocopherol, Niacinamide, Methylsilanol Hydroxyproline Aspartate, Lactobacillus, Hydrolyzed Triticum Monococcum Seed Extract, Maltodextrin, Sodium Chloride, Polyglyceryl-3 Diisostearate, Methicone, Xanthan Gum, Triethoxycaprylylsilane, Isopropyl Titanium Triisostearate, Polymethyl Methacrylate, Sodium Citrate, Dipropylene Glycol, Sodium Benzoate, Tetrasodium EDTA, Phenoxyethanol, Methylparaben, Ethylparaben, Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, 77492, 77499)

Principal Display Panel

Almay 

Smart Shade CC Luminous Primer

Broad Spectrum

SPF 15

1.0 fL. OZ/30 mL

INGREDIENTS AND APPEARANCE

ALMAY AGE SMART SHADE CC LUMINOUS PRIMER SPF 15 
zinc oxide, titanium dioxide make-up liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0311-0706
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	3.3 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM OXIDE (UNII: LMI26O6933)
XANTHAN GUM (UNII: TTV12P4NEE)
NIACINAMIDE (UNII: 25X51I8RD4)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE SODIUM (UNII: MP1J8420LU)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
SODIUM BENZOATE (UNII: OJ245FE5EU)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0311-0706-01	30 mL in 1 BOTTLE, GLASS; 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(0311-0706)