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

SunBurnt Advanced After-Sun by

Drug Labeling and Warnings

SunBurnt Advanced After-Sun by is a Homeopathic medication manufactured, distributed, or labeled by Denison Pharmaceuticals, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-1107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_Q]  in 0.1 g
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	1 [hp_Q]  in 0.1 g
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	3 [hp_X]  in 0.1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-1107-45	1 in 1 CARTON	01/01/2017
1		71 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0295-1107-24	1 in 1 CARTON	01/01/2017
2		170 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		01/01/2007

Labeler - Denison Pharmaceuticals, LLC. (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC.		001207208	manufacture(0295-1107)