Blistex®

Blistex®
SPL v3
SPL
SPL Set ID 86fc9f3c-e35f-4988-bf19-64d9c6c85ee9
Route
TOPICAL
Published
Effective Date 2024-02-09
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)
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-01-15

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • temporarily protects and helps relieve chapped or cracked lips
  • helps prevent sunburn
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
Dimethicone 2.0% (w/w) Lip protectant
Octinoxate 6.6% (w/w) Sunscreen
Octisalate 4.4% (w/w) Sunscreen
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, camphor, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavor, isopropyl myristate, lanolin, lanolin oil, menthol, mineral oil, ozokerite, paraffin, petrolatum, phenoxyethanol, polybutene, theobroma cacao (cocoa) seed butter, titanium dioxide

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.

Principal Display Panel 4.25 G Cylinder Carton

Blistex ®

LIP PROTECTANT/SUNSCREEN

MEDICATED

MINT BALM

Seals In Moisture

To Soothe & Prevent Dry Lips

Net Wt. 0.15 oz. (4.25 g)

SPF 15

Smooth

Easy-Gliding

Protection


Structured Label Content

Uses
  • temporarily protects and helps relieve chapped or cracked lips
  • helps prevent sunburn
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
Dimethicone 2.0% (w/w) Lip protectant
Octinoxate 6.6% (w/w) Sunscreen
Octisalate 4.4% (w/w) Sunscreen
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 (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, theobroma cacao (cocoa) seed butter, titanium dioxide

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.

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

Blistex ®

LIP PROTECTANT/SUNSCREEN

MEDICATED

MINT BALM

Seals In Moisture

To Soothe & Prevent Dry Lips

Net Wt. 0.15 oz. (4.25 g)

SPF 15

Smooth

Easy-Gliding

Protection


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)