NDC Code(s) : 51531-7497-8
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 Bronze 1octinoxate, octisalate, zinc oxide, oxybenzone, CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51531-7497
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 OXIDE2.4 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:51531-7497-81 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 not final part352 08/16/2006

PRINCIPAL DISPLAY PANEL

Mary Kay

tinted moisturizer with sunscreen spf 20

hydratant teinte avec ecran solaire fps 20

crema humectante con color y fps 20

1.5 FL. OZ. / 43 mL

Image of carton