sunburnt®

sunburnt®
SPL v4
SPL
SPL Set ID dcb2fd62-df8e-4a26-b7ed-274caefeeb76
Route
topical
Published
Effective Date 2018-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
calendula officinalis flower (1 [hp_Q]) echinacea angustifolia (3 [hp_X]) lytta vesicatoria
Inactive Ingredients
aloe vera leaf carbomer copolymer type a (allyl pentaerythritol crosslinked) alcohol panthenol phenoxyethanol water hyaluronate sodium sodium hydroxide

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2007-01-01 Until 2015-08-02

Description

Drug Facts


Medication Information

Warnings

For external use only

Uses

Temporarily relieves symptoms of mild and moderate sunburn such as:

  • overheated skin
  • redness
  • rawness
  • itching
  • dryness

Product Uses are based on the Homeopathic Materia Medica. These Uses have not been evaluated by the Food and Drug Administration.

Directions
  • for best results, clean skin and apply immediately to affected area
  • adults and children 2 years of age and older: apply 2-3 times a day, as needed, or as directed by your doctor
  • children under 2 years of age: consult a doctor
Other Information
  • store at 15-30ºC (59-86ºF)
  • do not use if tamper-evident seal under cap is compromised or missing
Inactive Ingredients

aloe barbadensis leaf juice, carbomer, ethyl alcohol, panthenol, phenoxyethanol, sodium hyaluronate, sodium hydroxide, water

Description

Drug Facts

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 53414-9

If pregnant or breast feeding, ask a health professional before use.

Section 55105-1
Active ingredients Purposes
The letters 'HPUS' indicate that the active ingredients are officially monographed in the Homeopathic Pharmacopoeia of the United States. TINC and 3X are homeopathic dilutions: see www.sunburnt.com for details.
Each dose contains:
8 parts Cantharis vesicatoria 3X HPUS Sunburns, rawness
1 part Calendula officinalis TINC HPUS Promotes skin healing
1 part Echinacea angustifolia TINC HPUS Itching, burning, redness
Do Not Use
  • on severe sunburn
  • on broken skin
  • if you have a rash
  • if you have an allergy or hypersensitivity to any ingredients
Questions Or Comments?

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

When Using This Product
  • avoid contact with eyes or mucous membranes
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 170 G Tube Carton

SUN

BURNT
®

ADVANCED SUN RECOVERY

AFTER-SUN GEL

MUCH MORE THAN ALOE ®

Immediately cools and rehydrates skin

Soothing relief for sunburned skin

Helps reduce the appearance

of redness & peeling

INSTANTLY

COOLING

ULTRA

HYDRATING

NON-STICKY

FORMULA

HOMEOPATHIC

Net Wt 6 oz (170 g)


Structured Label Content

Warnings

For external use only

Uses

Temporarily relieves symptoms of mild and moderate sunburn such as:

  • overheated skin
  • redness
  • rawness
  • itching
  • dryness

Product Uses are based on the Homeopathic Materia Medica. These Uses have not been evaluated by the Food and Drug Administration.

Directions
  • for best results, clean skin and apply immediately to affected area
  • adults and children 2 years of age and older: apply 2-3 times a day, as needed, or as directed by your doctor
  • children under 2 years of age: consult a doctor
Other Information (Other information)
  • store at 15-30ºC (59-86ºF)
  • do not use if tamper-evident seal under cap is compromised or missing
Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, carbomer, ethyl alcohol, panthenol, phenoxyethanol, sodium hyaluronate, sodium hydroxide, water

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 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients Purposes
The letters 'HPUS' indicate that the active ingredients are officially monographed in the Homeopathic Pharmacopoeia of the United States. TINC and 3X are homeopathic dilutions: see www.sunburnt.com for details.
Each dose contains:
8 parts Cantharis vesicatoria 3X HPUS Sunburns, rawness
1 part Calendula officinalis TINC HPUS Promotes skin healing
1 part Echinacea angustifolia TINC HPUS Itching, burning, redness
Do Not Use (Do not use)
  • on severe sunburn
  • on broken skin
  • if you have a rash
  • if you have an allergy or hypersensitivity to any ingredients
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 or mucous membranes
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 170 G Tube Carton (PRINCIPAL DISPLAY PANEL - 170 g Tube Carton)

SUN

BURNT
®

ADVANCED SUN RECOVERY

AFTER-SUN GEL

MUCH MORE THAN ALOE ®

Immediately cools and rehydrates skin

Soothing relief for sunburned skin

Helps reduce the appearance

of redness & peeling

INSTANTLY

COOLING

ULTRA

HYDRATING

NON-STICKY

FORMULA

HOMEOPATHIC

Net Wt 6 oz (170 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)