BLISTEX MEDICATED LIP BALM- dimethicone, octinoxate, and octisalate stick 
Blistex Inc

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Blistex® Medicated Lip Balm

Drug Facts

Active ingredients   Purpose
Dimethicone 2.0% (w/w)Lip protectant
Octinoxate 6.6% (w/w)Sunscreen
Octisalate 4.4% (w/w)Sunscreen

Uses

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

beeswax, camphor, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavor, isopropyl myristate, lanolin, lanolin oil, menthol, methyl salicylate, mineral oil, ozokerite, paraffin, petrolatum, phenoxyethanol, polybutene, red 6 lake, theobroma cacao (cocoa) seed butter, titanium dioxide

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton

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
BLISTEX MEDICATED LIP BALM 
dimethicone, octinoxate, and octisalate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-1119
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-1119-11 in 1 CARTON01/15/2018
14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
2NDC:10157-1119-33 in 1 CARTON01/15/2018
24.25 g in 1 CYLINDER; Type 0: Not a Combination Product
3NDC:10157-1119-44 in 1 CARTON01/15/2018
34.25 g in 1 CYLINDER; Type 0: Not a Combination Product
4NDC:10157-1119-55 in 1 CARTON12/16/2020
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 CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM01601/15/2018
Labeler - Blistex Inc (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc005126354MANUFACTURE(10157-1119)

Revised: 2/2024
Document Id: ea073bea-814d-4be1-b7cc-d71288674006
Set id: 8b4160ed-8889-4e3a-947f-a56c3324dbbe
Version: 4
Effective Time: 20240209
 
Blistex Inc