Sunburnt ®

Sunburnt ®
SPL v5
SPL
SPL Set ID 12de2559-05b0-4580-84c1-d3bd010b1c99
Route
TOPICAL
Published
Effective Date 2022-04-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Propanediol Aloe Vera Leaf Dimethyl Isosorbide Hydroxyethyl Cellulose (5500 Mpa.s At 2%) Phenoxyethanol Chlorphenesin .alpha.-tocopherol Acetate Water Caprylyl Glycol Calendula Officinalis Flower Panthenol Cucumber Seed Hyaluronate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-07-01 Until 2026-07-31

Description

Drug Facts

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Drug Facts

Uses

Temporarily relieves pain and itching due to:

  • sunburn
  • minor burns
  • insect bites
  • minor skin irritations
  • minor cuts
  • scrapes
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.

Warnings

For external use only

Directions
  • clean skin and apply to affected area
  • adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily
  • children under 2 years of age: ask a doctor
Do Not Use
  • in large quantities, particularly over raw surfaces or blistered areas
  • if you have an allergy or hypersensitivity to any ingredients
Active Ingredient

Lidocaine Hydrochloride 4.0%

Other Information
  • store at 15-30°C (59-86°F)
  • do not use if seal under cap is open or missing
Inactive Ingredients

Water, Propanediol,Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Calunda Officinalis Extract, Cucumis Sativus (Cucumber) Seed Extract, Panthenol, Dimethyl Isosorbide, Caprylyl Glycol, Chlorophenesin, Phenoxyethanol, Sodium Hyaluronate, Tocopheryl Acetate

Questions Or Comments?

Sunburnt.com

When Using This Product
  • Avoid contact with eyes
Stop Use and Ask A Doctor
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Ask A Doctor Before Use If
  • you have severe sunburn
  • you have a rash or broken or compromised skin
Principal Display Panel 118ml Tube Carton


Structured Label Content

Uses

Temporarily relieves pain and itching due to:

  • sunburn
  • minor burns
  • insect bites
  • minor skin irritations
  • minor cuts
  • scrapes
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.

Purpose

External analgesic

Warnings

For external use only

Directions
  • clean skin and apply to affected area
  • adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily
  • children under 2 years of age: ask a doctor
Do Not Use (Do not use)
  • in large quantities, particularly over raw surfaces or blistered areas
  • if you have an allergy or hypersensitivity to any ingredients
Active Ingredient

Lidocaine Hydrochloride 4.0%

Other Information
  • store at 15-30°C (59-86°F)
  • do not use if seal under cap is open or missing
Inactive Ingredients

Water, Propanediol,Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Calunda Officinalis Extract, Cucumis Sativus (Cucumber) Seed Extract, Panthenol, Dimethyl Isosorbide, Caprylyl Glycol, Chlorophenesin, Phenoxyethanol, Sodium Hyaluronate, Tocopheryl Acetate

Questions Or Comments? (Questions or Comments?)

Sunburnt.com

When Using This Product (When using this product)
  • Avoid contact with eyes
Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Ask A Doctor Before Use If (Ask a doctor before use if)
  • you have severe sunburn
  • you have a rash or broken or compromised skin
Principal Display Panel 118ml Tube Carton (PRINCIPAL DISPLAY PANEL - 118mL Tube Carton)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)