Sunburnt Advanced After-sun Gel
FDA Label NDC 24330-210

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Welmedix Llc for the product Sunburnt Advanced After-sun (NDC 24330-210). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Otc - Purpose

Active ingredientsPurposes
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 HPUSSunburns, rawness
1 part Calendula officinalis TINC HPUSPromotes skin healing
1 part Echinacea angustifolia TINC HPUSItching, burning, redness

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.

Warnings

For external use only

Do Not Use

  • 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

  • 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

Otc - Pregnancy Or Breast Feeding

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

Otc - 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.

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 15-30°C (59-86°F)
  • 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

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)

Principal Display Panel (170 g Tube Carton)

Principal Display Panel (170 g Tube Carton)

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