MEDICATED PEPPERMINT LIP BALM- dimethicone, unspecified, octinoxate, and octisalate stick

Medicated Peppermint Lip Balm by

Drug Labeling and Warnings

Medicated Peppermint Lip Balm by is a Otc medication manufactured, distributed, or labeled by Blistex Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

Uses

• temporarily protects and helps relieve chapped or cracked lips
• helps prevent sunburn

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

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• children under 6 months of age:
  Ask a doctor

Other information

• protect the product in this container from excessive heat and direct sun

Inactive ingredients

beeswax, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavors, isopropyl myristate, lanolin, lanolin oil, mentha piperita (peppermint) oil, menthol, mineral oil, ozokerite, paraffin, petrolatum, phenoxyethanol, polybutene, red 6 lake, saccharin, theobroma cacao (cocoa) seed butter

PRINCIPAL DISPLAY PANEL - 3 Stick Carton

Blistex®

LIMITED
EDITION

DERMATOLOGIST RECOMMENDED

MEDICATED PEPPERMINT BALM
LIP PROTECTANT/SUNSCREEN

SPF 15

3 Sticks
Net Wt. 0.15 oz. (4.25 g) Ea.

3 Pack

INGREDIENTS AND APPEARANCE

MEDICATED PEPPERMINT LIP BALM 
dimethicone, unspecified, octinoxate, and octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-4104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O) (DIMETHICONE, UNSPECIFIED - UNII:92RU3N3Y1O)	DIMETHICONE, UNSPECIFIED	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.6 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
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)
PEPPERMINT OIL (UNII: AV092KU4JH)
COCOA BUTTER (UNII: 512OYT1CRR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SACCHARIN (UNII: FST467XS7D)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
D&C RED NO. 6 (UNII: 481744AI4O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-4104-3	3 in 1 CARTON	08/01/2025
1		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product
2	NDC: 10157-4104-4	4 in 1 CARTON	08/01/2025
2		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	08/01/2025

Labeler - Blistex Inc (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc		005126354	MANUFACTURE(10157-4104)