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

Description

Drug Facts

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.

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
Warnings

For external use only

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
Do Not Use
  • on severe sunburn
  • on broken skin
  • if you have a rash
  • if you have an allergy or hypersensitivity to any ingredients
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

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

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.

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
Warnings

For external use only

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
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
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

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

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