SunBurnt ® Advanced After-Sun Gel

Label at a glance#

Contacts and useful links#

PhoneLabel contact1-888-565-2876

Websitewww.sunburnt.comwww.sunburnt.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• on severe sunburn
• on broken skin
• if you have a rash
• if you have an allergy or hypersensitivity to any ingredients

When using this product

OTC - WHEN USING SECTION

• avoid contact with eyes or mucous membranes

Stop use and ask a doctor if

OTC - STOP USE SECTION

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

• store at 15-30ºC (59-86ºF)
• do not use if tamper-evident seal under cap is compromised or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Dist. by: Welmedix Consumer Healthcare
Princeton, New Jersey 08540

SUNBURNT ADVANCED AFTER-SUN (CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, CANTHARIS VESICATORIA) GEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

• SunBurnt Advanced After-Sun
• Calendula Officinalis, Echinacea Angustifolia, Cantharis Vesicatoria
• CALENDULA OFFICINALIS FLOWER
• ECHINACEA ANGUSTIFOLIA
• LYTTA VESICATORIA
• ALOE VERA LEAF
• CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
• ALCOHOL
• PANTHENOL
• PHENOXYETHANOL
• WATER
• HYALURONATE SODIUM
• SODIUM HYDROXIDE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.