NDC Code(s) : 51531-4328-8
Packager : Mary Kay Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Mary Kay Tinted Moisturizer Sunscreen SPF 20 Ivory 1 (Drug Facts)octinoxate, octisalate, zinc oxide, oxybenzone, CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51531-4328
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE7.5 g in 100 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE2.43 g in 100 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE1.75 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
ISODODECANE(UNII: A8289P68Y2)
GLYCERIN(UNII: PDC6A3C0OX)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
BETAINE(UNII: 3SCV180C9W)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
DIMETHICONE PEG-7 PHOSPHATE(UNII: WTP86Y84TV)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)(UNII: 86FQE96TZ4)
SQUALANE(UNII: GW89575KF9)
METHYLPARABEN(UNII: A2I8C7HI9T)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
DMDM HYDANTOIN(UNII: BYR0546TOW)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
EDETATE DISODIUM(UNII: 7FLD91C86K)
PEG-4 LAURATE(UNII: AYF4VM3N1Z)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
POLYSORBATE 60(UNII: CAL22UVI4M)
1,3-BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
IODOPROPYNYL BUTYLCARBAMATE(UNII: 603P14DHEB)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
CHAMAEMELUM NOBILE FLOWER(UNII: O2T154T6OG)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51531-4328-81 in 1 CARTON
143 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 06/12/2012

PRINCIPAL DISPLAY PANEL

Mary Kay

tinted moisturizer

sunscreen

broad spectrum

spf 20

1.5 FL. OZ. / 43 mL

Image of carton