Sunburnt®

Sunburnt®
SPL v1
SPL
SPL Set ID 6363c695-f801-407d-a4e1-b0d9cfa0a273
Route
TOPICAL
Published
Effective Date 2018-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Alcohol Echinacea Angustifolia Calendula Officinalis Flowering Top Lytta Vesicatoria Gelidiella Acerosa Hypnea Musciformis Cucumber Seed Aloe Vera Leaf Panthenol Hyaluronate Sodium Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Sodium Hydroxide Phenoxyethanol Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-03-15

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 1.0%

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

water, ethyl alcohol, echinacea angustifolia extract, calendula officinalis extract, cantharis vesicatoria extract, gelidiella acerosa extract, hypnea musciformis extract, cucumis sativus (cucumber) seed extract, aloe barbadensis leaf juice, panthenol, sodium hyaluronate, carbomer, sodium hydroxide, phenoxyethanol, ethylhexylglycerin

Questions Or Comments?

1-888-565-2876 Monday through Friday, 9am-5pm EST

When Using This Product
  • avoid contact with eyes
Ask A Doctor Before Use If
  • you have severe sunburn
  • you have a rash or broken or compromised skin
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 142 G Tube Carton

NEW!

SUN

BURNT®

PLUS

PAIN RELIEF GEL

with LIDOCAINE HCL 1%

FAST RELIEF FOR

PAIN & ITCH

ULTRA

HYDRATING

NOURISHING

BOTANICALS

NON-STICKY

FORMULA

Net Wt 5 oz (142 g)


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 (Active ingredient)

Lidocaine hydrochloride 1.0%

Other Information (Other information)
  • store at 15-30ºC (59-86ºF)
  • do not use if seal under cap is open or missing
Inactive Ingredients (Inactive ingredients)

water, ethyl alcohol, echinacea angustifolia extract, calendula officinalis extract, cantharis vesicatoria extract, gelidiella acerosa extract, hypnea musciformis extract, cucumis sativus (cucumber) seed extract, aloe barbadensis leaf juice, panthenol, sodium hyaluronate, carbomer, sodium hydroxide, phenoxyethanol, ethylhexylglycerin

Questions Or Comments? (Questions or Comments?)

1-888-565-2876 Monday through Friday, 9am-5pm EST

When Using This Product (When using this product)
  • avoid contact with eyes
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
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 142 G Tube Carton (PRINCIPAL DISPLAY PANEL - 142 g Tube Carton)

NEW!

SUN

BURNT®

PLUS

PAIN RELIEF GEL

with LIDOCAINE HCL 1%

FAST RELIEF FOR

PAIN & ITCH

ULTRA

HYDRATING

NOURISHING

BOTANICALS

NON-STICKY

FORMULA

Net Wt 5 oz (142 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)