NDC Code(s) : 51531-8360-1, 51531-8360-5
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 SPF 35avobenzone, homosalate, octisalate, octocrylene, oxybenzone SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51531-8360
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE2 g in 100 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE10 g in 100 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE2 g in 100 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE4 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
GLYCERIN(UNII: PDC6A3C0OX)
CETEARETH-25(UNII: 8FA93U5T67)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
DIPROPYLENE GLYCOL DIBENZOATE(UNII: 6OA5ZDY41O)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE(UNII: QI9A6U005W)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
XANTHAN GUM(UNII: TTV12P4NEE)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PPG-15 STEARYL ETHER BENZOATE(UNII: 80D2J6361M)
EDETATE DISODIUM(UNII: 7FLD91C86K)
PEG-4 LAURATE(UNII: AYF4VM3N1Z)
SORBIC ACID(UNII: X045WJ989B)
LAURETH-3(UNII: F32E4CB0UJ)
IODOPROPYNYL BUTYLCARBAMATE(UNII: 603P14DHEB)
ACETYL DIPEPTIDE-1 CETYL ESTER(UNII: 3M7W78X5IR)
AMMONIA(UNII: 5138Q19F1X)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CRITHMUM MARITIMUM(UNII: J7IHY79BKY)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
METHYLPARABEN(UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 7000(UNII: Q0JET65GEL)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51531-8360-11 in 1 CARTON
129 mL in 1 BOTTLE, PUMP
2NDC:51531-8360-514 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 03/01/2012

PRINCIPAL DISPLAY PANEL

Mary Kay

timewise day solution

sunscreen

broad spectrum

spf 35

1 FL. OZ. / 29 mL

Image of carton