NDC Code(s) : 51531-5396-6
Packager : Mary Kay Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Mary Kay Tinted Lip Balm Sunscreen SPF 15 Poppyoctinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51531-5396
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE5 g in 100 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE3 g in 100 g
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE5 g in 100 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE7.99 g in 100 g
Inactive Ingredients
Ingredient Name Strength
PENTAERYTHRITYL TETRAISOSTEARATE(UNII: 9D7IK5483F)
LANOLIN(UNII: 7EV65EAW6H)
OCTYLDODECANOL(UNII: 461N1O614Y)
CANDELILLA WAX(UNII: WL0328HX19)
SHEA BUTTER(UNII: K49155WL9Y)
MICROCRYSTALLINE WAX(UNII: XOF597Q3KY)
CARNAUBA WAX(UNII: R12CBM0EIZ)
CASTOR OIL(UNII: D5340Y2I9G)
JOJOBA OIL(UNII: 724GKU717M)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS(UNII: 137SL7IL0Y)
C30-50 ALCOHOLS(UNII: 4MCU204619)
TRIHYDROXYSTEARIN(UNII: 06YD7896S3)
VANILLIN(UNII: CHI530446X)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PHYTANTRIOL(UNII: 8LVI07A72W)
SORBITOL(UNII: 506T60A25R)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
TOCOPHEROL(UNII: R0ZB2556P8)
HYALURONIC ACID(UNII: S270N0TRQY)
TILIROSIDE(UNII: 15M04TXR9M)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C RED NO. 7(UNII: ECW0LZ41X8)
D&C RED NO. 27(UNII: 2LRS185U6K)
D&C RED NO. 30(UNII: 2S42T2808B)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51531-5396-61 in 1 CARTON
11.75 g in 1 CARTRIDGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/16/2009

PRINCIPAL DISPLAY PANEL

Mary Kay

tinted lip balm sunscreen

spf 15

crema humectante para labios con color y fps 15

.06 OZ. NET WT. / 1.75 g / 1,75 g

Image of carton