NDC Code(s) : 0311-0706-01
Packager : Almay, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Almay Age Smart Shade CC Luminous Primer SPF 15Zinc Oxide, Titanium Dioxide Make-Up LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0311-0706
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION3.3 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE4.3 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
1NDC:0311-0706-0130 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product14/11/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 11/14/2013

LABELER - Almay, Inc.(064988652)

Establishment
Name Address ID/FEI Business Operations
REVLON, INC. 809725570 manufacture(0311-0706)

PRINCIPAL DISPLAY PANEL

Almay 

Smart Shade CC Luminous Primer

Broad Spectrum

SPF 15

1.0 fL. OZ/30 mL

image description