Blistex®

Blistex®
SPL v2
SPL
SPL Set ID 47b57317-7df5-442e-a3a4-1d44fe278ac6
Route
TOPICAL
Published
Effective Date 2024-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (15 g) Octisalate (5 g) Avobenzone (3 g) Dimethicone (2 g)
Inactive Ingredients
Microcrystalline Wax Ceresin Octyldodecanol Butyloctyl Salicylate Alkyl (c12-15) Benzoate Myristyl Myristate Stearyl Behenate Cetyl Dimethicone 25 Stearyl Dimethicone (400 Mpa.s At 50c) Bis-diglyceryl Polyacyladipate-2 Candelilla Wax Oryzanol .alpha.-tocopherol Acetate Tetrahexyldecyl Ascorbate Phenoxyethanol Medium-chain Triglycerides Calendula Officinalis Flower Safflower Oil Wheat Germ Oil Sucralose Citric Acid Monohydrate Sorbic Acid Panthenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-22
Description

Drug Facts

Medication Information

Description

Drug Facts

Uses
  • temporarily protects and helps relieve chapped or cracked lips
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin

Section 55105-1
Active ingredients Purpose
Avobenzone 3.0% (w/w) Sunscreen
Dimethicone 2.0% (w/w) Lip Protectant
Homosalate 15.0 % (w/w) Sunscreen
Octisalate 5.0 % (w/w) Sunscreen
Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • children under 6 months of age: Ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m.-2 p.m.
    • wear long sleeve shirts, pants, hats, and sunglasses
Other Information
  • protect the product in this container from excessive heat and direct sun
Inactive Ingredients

bis-diglyceryl polyacyladipate-2, bis-stearyl dimethicone, butyloctyl salicylate, C12-15 alkyl benzoate, calendula officinalis extract, caprylic/capric triglyceride, carthamus tinctorius (safflower) seed oil, cetyl dimethicone, citric acid, euphorbia cerifera (candelilla) wax, flavor, microcrystalline wax, myristyl myristate, octyldodecanol, oryzanol, ozokerite, panthenol, phenoxyethanol, sorbic acid, stearyl behenate, sucralose, tetrahexyldecyl ascorbate, tocopheryl acetate, triticum vulgare (wheat) germ oil

Principal Display Panel 4.25 G Cylinder Blister Pack

The Ultimate

Daily Protection

For Lips

Blistex®

FIVE STAR

Lip Protection®

Structured Label Content

Uses
  • temporarily protects and helps relieve chapped or cracked lips
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 55105-1 (55105-1)
Active ingredients Purpose
Avobenzone 3.0% (w/w) Sunscreen
Dimethicone 2.0% (w/w) Lip Protectant
Homosalate 15.0 % (w/w) Sunscreen
Octisalate 5.0 % (w/w) Sunscreen
Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • children under 6 months of age: Ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m.-2 p.m.
    • wear long sleeve shirts, pants, hats, and sunglasses
Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
Inactive Ingredients (Inactive ingredients)

bis-diglyceryl polyacyladipate-2, bis-stearyl dimethicone, butyloctyl salicylate, C12-15 alkyl benzoate, calendula officinalis extract, caprylic/capric triglyceride, carthamus tinctorius (safflower) seed oil, cetyl dimethicone, citric acid, euphorbia cerifera (candelilla) wax, flavor, microcrystalline wax, myristyl myristate, octyldodecanol, oryzanol, ozokerite, panthenol, phenoxyethanol, sorbic acid, stearyl behenate, sucralose, tetrahexyldecyl ascorbate, tocopheryl acetate, triticum vulgare (wheat) germ oil

Principal Display Panel 4.25 G Cylinder Blister Pack (PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Blister Pack)

The Ultimate

Daily Protection

For Lips

Blistex®

FIVE STAR

Lip Protection®

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:45.123949 · Updated: 2026-03-14T23:05:41.137982