NDC Code(s) : 51531-4399-7
Packager : Mary Kay Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Mary Kay TimeWise Repair VoluFirm Day Cream SPF 30avobenzone, homosalate, octisalate, octocrylene, oxybenzone CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51531-4399
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 g
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE5 g in 100 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE2 g in 100 g
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE4 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
DIMETHICONE(UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
PHENETHYL BENZOATE(UNII: 0C143929GK)
POLYESTER-7(UNII: 0841698D2F)
DOCOSANOL(UNII: 9G1OE216XY)
NEOPENTYL GLYCOL DIHEPTANOATE(UNII: 5LKW3C543X)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
POTASSIUM CETYL PHOSPHATE(UNII: 03KCY6P7UT)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)(UNII: 86FQE96TZ4)
TRISILOXANE(UNII: 9G1ZW13R0G)
ARACHIDYL ALCOHOL(UNII: 1QR1QRA9BU)
HYDROGENATED PALM GLYCERIDES(UNII: YCZ8EM144Q)
DIPROPYLENE GLYCOL DIBENZOATE(UNII: 6OA5ZDY41O)
SHEA BUTTER(UNII: K49155WL9Y)
SQUALANE(UNII: GW89575KF9)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
DIMETHYL CAPRAMIDE(UNII: O29Y6X2JEZ)
METHYL DIHYDROJASMONATE (SYNTHETIC)(UNII: 3GW44CIE3Y)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
HEXYLRESORCINOL(UNII: R9QTB5E82N)
METHYL TRIMETHICONE(UNII: S73ZQI0GXM)
PEG-100 STEARATE(UNII: YD01N1999R)
4-TERT-BUTYLCYCLOHEXANOL(UNII: K0H1405S9C)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
XANTHAN GUM(UNII: TTV12P4NEE)
ARACHIDYL GLUCOSIDE(UNII: 6JVW35JOOJ)
ETHYLENE BRASSYLATE(UNII: 9A87HC7ROD)
DECYLENE GLYCOL(UNII: S57M60MI88)
ETHYL LINALOOL(UNII: SF2JS9GF5T)
POLYSORBATE 60(UNII: CAL22UVI4M)
EDETATE DISODIUM(UNII: 7FLD91C86K)
PANTHENOL(UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ALLANTOIN(UNII: 344S277G0Z)
TRIMETHYLBENZENEPROPANOL(UNII: 7S411YY2VY)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
CESTRUM LATIFOLIUM LEAF(UNII: O2618B6E88)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51531-4399-71 in 1 CARTON
148 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 07/16/2012

PRINCIPAL DISPLAY PANEL

Mary Kay

timewise  repair

volu-firm day cream

sunscreen

broad spectrum

spf 30

1.7 OZ. NET WT. / 48 g

Image of carton