NDC Code(s) : 51531-0332-3
Packager : Mary Kay Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MKMen Moisturizer Sunscreen Broad Spectrum SPF 25avobenzone, homosalate, octinoxate, octisalate, oxybenzone LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51531-0332
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE3 g in 100 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE10 g in 100 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE7.5 g in 100 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S)(UNII: 587WKM3S9Q)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
1,3-BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PEG-100 STEARATE(UNII: YD01N1999R)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)(UNII: 86FQE96TZ4)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
DIMETHICONE(UNII: 92RU3N3Y1O)
SQUALANE(UNII: GW89575KF9)
LEVOMENOL(UNII: 24WE03BX2T)
BENZYL ALCOHOL(UNII: LKG8494WBH)
XANTHAN GUM(UNII: TTV12P4NEE)
METHYLPARABEN(UNII: A2I8C7HI9T)
STEARETH-2(UNII: V56DFE46J5)
CHLORPHENESIN(UNII: I670DAL4SZ)
POLYSORBATE 60(UNII: CAL22UVI4M)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
EDETATE DISODIUM(UNII: 7FLD91C86K)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
ETHYLPARABEN(UNII: 14255EXE39)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51531-0332-31 in 1 CARTON
188 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 06/16/2007

PRINCIPAL DISPLAY PANEL

mkmen

MOISTURIZER SUNSCREEN

BROAD SPECTRUM SPF 25

3 FL. OZ. / 88 mL

Image of carton