Label: SUNBURNT ADVANCED AFTER-SUN- calendula officinalis, echinacea angustifolia, cantharis vesicatoria gel

  • NDC Code(s): 24330-210-01, 24330-210-03, 24330-210-06, 24330-210-21
  • Packager: Welmedix LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated March 20, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    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

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

    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 15-30ºC (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

  • SPL UNCLASSIFIED SECTION

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

  • 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
  • INGREDIENTS AND APPEARANCE
    SUNBURNT ADVANCED AFTER-SUN 
    calendula officinalis, echinacea angustifolia, cantharis vesicatoria gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24330-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_Q]  in 0.1 g
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA1 [hp_Q]  in 0.1 g
    LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA3 [hp_X]  in 0.1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    ALCOHOL (UNII: 3K9958V90M)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24330-210-061 in 1 CARTON09/01/2016
    1170 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:24330-210-031 in 1 CARTON09/01/2016
    271 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:24330-210-011 in 1 POUCH08/01/201509/01/2016
    37.1 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:24330-210-211 in 1 CARTON08/01/201508/02/2015
    421.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic01/01/2007
    Labeler - Welmedix LLC (830387812)
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