NDC Code(s) : 10157-1119-1, 10157-1119-3, 10157-1119-4, 10157-1119-5, 10157-1119-2
Packager : Blistex Inc

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Blistex Medicated Lip BalmDIMETHICONE, OCTINOXATE, and OCTISALATE STICK
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10157-1119
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE2 g in 100 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE6.6 g in 100 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE4.4 g in 100 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL(UNII: T5L8T28FGP)
PETROLATUM(UNII: 4T6H12BN9U)
CERESIN(UNII: Q1LS2UJO3A)
CANDELILLA WAX(UNII: WL0328HX19)
LANOLIN OIL(UNII: OVV5IIJ58F)
YELLOW WAX(UNII: 2ZA36H0S2V)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
LANOLIN(UNII: 7EV65EAW6H)
POLYBUTENE (1400 MW)(UNII: 1NA5AO9GH7)
CETYL PALMITATE(UNII: 5ZA2S6B08X)
CETYL ALCOHOL(UNII: 936JST6JCN)
PARAFFIN(UNII: I9O0E3H2ZE)
COCOA BUTTER(UNII: 512OYT1CRR)
MENTHOL, UNSPECIFIED FORM(UNII: L7T10EIP3A)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
.ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR(UNII: F89Z8SAG3O)
METHYL SALICYLATE(UNII: LAV5U5022Y)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C RED NO. 6(UNII: 481744AI4O)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10157-1119-11 in 1 CARTON 15/01/2018
14.25 g in 1 CYLINDER Type 0: Not a Combination Product
2NDC:10157-1119-33 in 1 CARTON 15/01/2018
24.25 g in 1 CYLINDER Type 0: Not a Combination Product
3NDC:10157-1119-44 in 1 CARTON 15/01/2018
34.25 g in 1 CYLINDER Type 0: Not a Combination Product
4NDC:10157-1119-55 in 1 CARTON 16/12/2020
44.25 g in 1 CYLINDER Type 0: Not a Combination Product
5NDC:10157-1119-24.25 g in 1 CYLINDER Type 0: Not a Combination Product02/08/2024
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph drug M016 01/15/2018

LABELER - Blistex Inc(005126354)

Establishment
Name Address ID/FEI Business Operations
Blistex Inc 005126354 MANUFACTURE(10157-1119)

PRINCIPAL DISPLAY PANEL

Blistex®
LIP PROTECTANT/SUNSCREEN

MEDICATED
LIP BALM

Seals In Moisture
To Soothe & Prevent Dry Lips

Net Wt. 0.15 oz. (4.25 g)
SPF 15

Smooth
Easy-Gliding
Protection

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton