Dimethicone, Octinoxate, and Octisalate

Manufacturer
Blistex Inc
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:43:54

Label at a glance#

ProductBlistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medica...
Active ingredientDIMETHICONE, OCTINOXATE, OCTISALATE
Label structure8 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

beeswax, camphor, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavors, isopropyl myristate, lanolin, lanolin oil, menthol, methyl salicylate1, mineral oil, ozokerite, paraffin, petrolatum, phenoxyethanol, polybutene, red 6 lake1, theobroma cacao (cocoa) seed butter, titanium dioxide

1 may contain these ingredients

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUE
PACK

Blistex®
LIP PROTECTANT/SUNSCREEN

Mint
Berry
Classic

MEDICATED
LIP BALM

Smooth, Easy-Gliding
Protection

Seals In Moisture
To Soothe & Prevent
Dry Lips

SPF 15

3 Balm
VALUE
PACK

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

Principal Display Panel - Kit Carton
Principal Display Panel - Kit Carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-9908-1Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Mint Lip Balm)1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-9908BLISTEX MEDICATED LIP BALM VARIETY PACK (BLISTEX MEDICATED BERRY LIP BALM, BLISTEX MEDICATED LIP BALM, BLISTEX MEDICATED MINT LIP BALM) (DIMETHICONE, OCTINOXATE, AND OCTISALATE) KIT [BLISTEX INC]2Current NDC, Legacy NDC, 1 package rows20241218_24e1d2fc-3f9d-4e86-a397-61bfbfc4d58c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10157-990810157-9908-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 63 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Mint Lip Balm)DIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc24e1d2fc-3f9d-4e86-a397-61bfbfc4d58c2024-12-16WarningsExact identifier
ndc (package): 10157-9908-1
ndc (product): 10157-9908
ndc11 (package): 10157990801
spl id: 4de85caa-d3ea-48db-9d5a-1523099377c2
spl set id: 24e1d2fc-3f9d-4e86-a397-61bfbfc4d58c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.