FDA.reportPublic FDA data

SunBurnt ® Advanced After-Sun Gel

Manufacturer
Welmedix LLC
Effective date
2018-03-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:09:18

Label at a glance#

ProductSunBurnt Advanced After-Sun
Active ingredientCALENDULA OFFICINALIS FLOWER, ECHINACEA ANGUSTIFOLIA, LYTTA VESICATORIA
Label structure10 sections

Indications and 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.

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24330-210-01SunBurnt Advanced After-Sun7.1 g in 1 TUBEGEL7.14
24330-210-01SunBurnt Advanced After-Sun1 in 1 POUCHGEL14
24330-210-03SunBurnt Advanced After-Sun1 in 1 CARTONGEL14
24330-210-03SunBurnt Advanced After-Sun71 g in 1 TUBEGEL714
24330-210-06SunBurnt Advanced After-Sun170 g in 1 TUBEGEL1704
24330-210-06SunBurnt Advanced After-Sun1 in 1 CARTONGEL14
24330-210-21SunBurnt Advanced After-Sun1 in 1 CARTONGEL14
24330-210-21SunBurnt Advanced After-Sun21.3 g in 1 TUBEGEL21.34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24330-210SUNBURNT ADVANCED AFTER-SUN (CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, CANTHARIS VESICATORIA) GEL [WELMEDIX LLC]4Current NDC, Legacy NDC, 8 package rows20180404_dcb2fd62-df8e-4a26-b7ed-274caefeeb76.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24330-210-06ML - Milliliter24330-210823e05c8-e929-4e5a-b980-d46f603e83f522024-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALENDULA OFFICINALIS FLOWERACTIVE INGREDIENTP0M7O4Y7YD3
ECHINACEA ANGUSTIFOLIAACTIVE INGREDIENTVB06AV5US83
LYTTA VESICATORIAACTIVE INGREDIENT3Q034RO3BT3
CALENDULA OFFICINALIS FLOWERACTIVE MOIETYP0M7O4Y7YD3
ECHINACEA ANGUSTIFOLIAACTIVE MOIETYVB06AV5US83
LYTTA VESICATORIAACTIVE MOIETY3Q034RO3BT3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X3
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995L3
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH3
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24330-21024330-210-06, 24330-210-03, 24330-210-01, 24330-210-21

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
ALCOHOL3K9958V90MIACT
PANTHENOLWV9CM0O67ZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
5 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
5 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
5 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
5 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
5 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SunBurnt Advanced After-SunCALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, CANTHARIS VESICATORIAWelmedix LLCdcb2fd62-df8e-4a26-b7ed-274caefeeb762018-03-20WarningsExact identifier
ndc (package): 24330-210-21
ndc (package): 24330-210-06
ndc (package): 24330-210-01
ndc (package): 24330-210-03
ndc (product): 24330-210
ndc11 (package): 24330021006
ndc11 (package): 24330021003
ndc11 (package): 24330021001
ndc11 (package): 24330021021
spl id: 3d715022-70be-44aa-bfa3-f37823e35421
spl set id: dcb2fd62-df8e-4a26-b7ed-274caefeeb76

Reported adverse events (FAERS/openFDA)#

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