ALMAY SMART SHADE CC CREAM- octinoxate, octisalate, titanium dioxide make-up liquid

Almay Smart Shade CC Cream by

Drug Labeling and Warnings

Almay Smart Shade CC Cream by is a Otc medication manufactured, distributed, or labeled by Almay, REVLON, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Octinoxate 7.5%

Octosalate 5.0%

Titanium Dioxide 5.1%

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,NEOPENTYL GLYCOL DIHEPTANOATE,BUTYLENE GLYCOL,GLYCERIN,PENTAERYTHRITYL TETRAISOSTEARATE,PHENYL TRIMETHICONE,GLYCERYL STEARATE,TRIDECYL TRIMELLITATE,ISOTRIDECYL ISONONANOATE,ISOSTEARIC ACID,BORON NITRIDE,ALUMINA,PALMITOYL TRIPEPTIDE-5,ACETYL HEXAPEPTIDE-8,GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT,VITIS VINIFERA (GRAPE) FRUIT EXTRACT,SAXIFRAGA SARMENTOSA (STRAWBERRY SAXIFRAGE) EXTRACT,SODIUM HYALURONATE,HYDROLYZED GLYCOSAMINOGLYCANS,SCUTELLARIA BAICALENSIS (BAIKAL SKULLCAP) ROOT EXTRACT,MORUS BOMBYCIS(CHINES MULBERRY) ROOT EXTRACT,ASCORBYL GLUCOSIDE,NIACINAMIDE,DIPOTASSIUM GLYCYRRHIZATE,C13-14 ISOPARAFFIN,XANTHAN GUM,SIMETHICONE,LAURETH-7,LECITHIN,SORBITAN LAURATE,POLYSORBATE 20,PROPYLENE GLYCOL LAURATE,PROPYLENE GLYCOL STEARATE,METHICONE,STEARIC ACID,STEARETH-2,TROMETHAMINE,POLYACRYLAMIDE,POLYMETHYL METHACRYLATE,STEARETH-21,PHENOXYETHANOL,METHYLPARABEN,ETHYLPARABEN

May Contain Mica, Titanium Dioxide (Ci 77891), Iron Oxides (CI 77491, 77492, 77499)

Principal Display Panel:

​Almay

Smart Shade CC CREAM

SKIN PERFECTOR

BROAD SPECTRUM

SPF 30

1.0 fL. OZ/30 mL

INGREDIENTS AND APPEARANCE

ALMAY SMART SHADE CC CREAM 
octinoxate, octisalate, titanium dioxide make-up liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0311-0705
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
TROMETHAMINE (UNII: 023C2WHX2V)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)
ISOSTEARIC ACID (UNII: X33R8U0062)
BORON NITRIDE (UNII: 2U4T60A6YD)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
STEARETH-2 (UNII: V56DFE46J5)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
STEARETH-21 (UNII: 53J3F32P58)
METHICONE (20 CST) (UNII: 6777U11MKT)
XANTHAN GUM (UNII: TTV12P4NEE)
LAURETH-7 (UNII: Z95S6G8201)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL LAURATES (UNII: 40KT317HGP)
PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
VITIS VINIFERA FRUIT OIL (UNII: YQ5Q4Y2Z8U)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
MORUS ALBA ROOT (UNII: CST1G9BZGD)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PEG-10 SORBITAN LAURATE (UNII: 4Z93U4C2WN)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0311-0705-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	04/22/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/22/2013

Labeler - Almay (064988652)

Establishment
Name	Address	ID/FEI	Business Operations
REVLON, INC.		809725570	manufacture(0311-0705)