NDC Code(s) : 51531-2326-1, 51531-2326-5
Packager : Mary Kay Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Mary Kay TimeWise Day Solution Sunscreen SPF 25octinoxate, octisalate, zinc oxide, oxybenzone, LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51531-2326
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 OXIDE3.88 g in 100 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE3 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
ISODODECANE(UNII: A8289P68Y2)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
NYLON-12(UNII: 446U8J075B)
GLYCERIN(UNII: PDC6A3C0OX)
BETAINE(UNII: 3SCV180C9W)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
DIMETHICONE(UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
1,3-BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PEG-100 STEARATE(UNII: YD01N1999R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
DIMETHICONE PEG-7 PHOSPHATE(UNII: WTP86Y84TV)
MICA(UNII: V8A1AW0880)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)(UNII: 86FQE96TZ4)
SQUALANE(UNII: GW89575KF9)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
METHYLPARABEN(UNII: A2I8C7HI9T)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
EDETATE DISODIUM(UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
PEG-4 LAURATE(UNII: AYF4VM3N1Z)
POLYSORBATE 60(UNII: CAL22UVI4M)
LAURETH-3(UNII: F32E4CB0UJ)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
ETHYLPARABEN(UNII: 14255EXE39)
ISOBUTYLPARABEN(UNII: 0QQJ25X58G)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
IODOPROPYNYL BUTYLCARBAMATE(UNII: 603P14DHEB)
ACETYL DIPEPTIDE-1 CETYL ESTER(UNII: 3M7W78X5IR)
STANNIC OXIDE(UNII: KM7N50LOS6)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CRITHMUM MARITIMUM(UNII: J7IHY79BKY)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
CHLORPHENESIN(UNII: I670DAL4SZ)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 7000(UNII: Q0JET65GEL)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51531-2326-11 in 1 CARTON
129 mL in 1 BOTTLE, PUMP
2NDC:51531-2326-514 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/16/2005

PRINCIPAL DISPLAY PANEL

Mary Kay

timewise

day solution sunscreen spf 25

solution diurne ecran solaire fps 25

locion facial humectante para el dia fps 25

1 FL. OZ. / 29 mL

Image of carton