Blistex®

Blistex®
SPL v3
SPL
SPL Set ID 4121d671-521c-4f36-b2db-652c13f730c6
Route
TOPICAL
Published
Effective Date 2024-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (2 g) Octinoxate (6.6 g) Octisalate (4.4 g) Camphor (synthetic) (1.1 g) Menthol, Unspecified Form (0.5 g) Phenol (0.625 g)
Inactive Ingredients
Mineral Oil Petrolatum Ceresin Candelilla Wax Lanolin Oil Yellow Wax Isopropyl Myristate Lanolin Polybutene (1400 Mw) Cetyl Palmitate Cetyl Alcohol Paraffin Cocoa Butter Menthol, Unspecified Form Phenoxyethanol .alpha.,.alpha.-dibromo-d-camphor Titanium Dioxide D&c Red No. 6 Methyl Salicylate Water Polyglyceryl-3 Diisostearate Alcohol Ammonia Glycerin Allantoin Peppermint Oil Hydrated Silica Palmitic Acid Stearyl Alcohol Calcium Hydroxide Lauric Acid Myristic Acid Sodium Hydroxide Oleic Acid Edetate Calcium Disodium Anhydrous Potassium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-03

Description

MEDICATED BERRY BALM Drug Facts


Medication Information

Description

MEDICATED BERRY BALM Drug Facts

Uses
  • temporarily protects and helps relieve chapped or cracked lips
  • helps prevent sunburn
Section 42229-5

MEDICATED BERRY BALM

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

For external use only

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
Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
Other Information
  • protect the product in this container from excessive heat and direct sun
Inactive Ingredients

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

When Using This Product
  • do not get into eyes
  • do not apply over large areas of the body or bandage
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.

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Principal Display Panel Kit Carton

Blistex® MEDICATED VARIETY PACK

Helps heal, soothe

& protect

There's No Bliss Like Blistex®


Structured Label Content

Uses
  • temporarily protects and helps relieve chapped or cracked lips
  • helps prevent sunburn
Section 42229-5 (42229-5)

MEDICATED BERRY BALM

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

For external use only

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
Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns
Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
Inactive Ingredients (Inactive ingredients)

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

When Using This Product (When using this product)
  • do not get into eyes
  • do not apply over large areas of the body or bandage
Skin Cancer/skin Aging Alert (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.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

Blistex® MEDICATED VARIETY PACK

Helps heal, soothe

& protect

There's No Bliss Like Blistex®


Advanced Ingredient Data


Raw Label Data

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