Sun Burnt ®

Sun Burnt ®
SPL v1
SPL
SPL Set ID 12128c75-015d-8a72-e063-6394a90ae00a
Route
TOPICAL
Published
Effective Date 2024-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Aloe Vera Leaf Limosilactobacillus Fermentum Hydroxyethyl Cellulose (5500 Mpa.s At 2%) Phenoxyethanol Water Calendula Officinalis Flower Panthenol Hyaluronate Sodium Echinacea Purpurea Root Glycerin Mannitol Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-23
Description

Drug Facts

Purpose

Topical Pain Relief

Medication Information

Purpose

Topical Pain Relief

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

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%

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

Water, Hydroxyethylcellulose,Glycerin, Phenoxyethanol, Aloe Barbadensis Leaf Juice, D-Panthenol, Calunda Officinalis Extract, Echinacea Purpurea Root Extract, Mannitol, Sodium Hyaluronate, Lactobacillus Ferment, Sodium Hydroxide

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
Keep Out of Reach of Children

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

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

Purpose

Topical Pain Relief

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%

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

Water, Hydroxyethylcellulose,Glycerin, Phenoxyethanol, Aloe Barbadensis Leaf Juice, D-Panthenol, Calunda Officinalis Extract, Echinacea Purpurea Root Extract, Mannitol, Sodium Hyaluronate, Lactobacillus Ferment, Sodium Hydroxide

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
Keep Out of Reach of Children (Keep out of reach of children)

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

Principal Display Panel 118ml Tube Carton (PRINCIPAL DISPLAY PANEL - 118mL Tube Carton)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:48.468350 · Updated: 2026-03-14T23:02:33.495898