Medicated Peppermint Lip Balm
Medicated Peppermint Lip Balm
5d48a6fa-ddce-47c3-9b09-1f3abb695017
HUMAN OTC DRUG LABEL
Jul 18, 2025
Blistex Inc
DUNS: 005126354
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dimethicone, UNSPECIFIED, Octinoxate, and Octisalate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (21)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
INDICATIONS & USAGE SECTION
Uses
- temporarily protects and helps relieve chapped or cracked lips
- helps prevent sunburn
OTC - ACTIVE INGREDIENT SECTION
|
Active ingredients |
Purpose |
|---|---|
|
Dimethicone 2.0% (w/w) |
Lip protectant |
|
Octinoxate 6.6% (w/w) |
Sunscreen |
|
Octisalate 4.4% (w/w) |
Sunscreen |
SPL UNCLASSIFIED SECTION
Other information
- protect the product in this container from excessive heat and direct sun
WARNINGS SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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
INACTIVE INGREDIENT SECTION
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