ULTRA V IDEBENONE SUNBLOCK- homosalate, avobenzone, ensulizole cream

Ultra V IDEBENONE SUNBLOCK by

Drug Labeling and Warnings

Ultra V IDEBENONE SUNBLOCK by is a Otc medication manufactured, distributed, or labeled by Ultra V Co., Ltd, Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Homosalate 10%, Butyl Methoxydibenzoylmethane 3.5%, Phenylbenzimidazole Sulfonic Acid 3.5%

INACTIVE INGREDIENT

Inactive ingredients: Water, Glycerin, Acrylates Copolymer, Dibutyl Adipate, Methyl Methacrylate Crosspolymer, Niacinamide, Propanediol, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Pentylene Glycol, Alcohol Denat., Aminomethyl Propanol, Caprylyl Methicone, Polymethylsilsesquioxane, Dimethicone, Behenyl Alcohol, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Carbomer, Phenoxyethandl, Tromethamine, Caprylyl Glycol, Xanthan Gum, Adenosine, Disodium EDTA, Boswellia Carterii Oil, Pelargonium Graveolens Flower Oil, Vetiveria Zizanoides Root Oil, Amyris Balsamifera Bark Oil, Butylene Glycol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Daucus Carota Sativa (Carrot) Seed Oil, Hydrocydecyl Ubiquinone, Tocopheryl Acetate, Macadamia Integrifolia Seed Oil, Anthemis Nobilis Flower Water, Octyldodecanol, Curcuma Longa (Turmeric) Root Extract, Rice Ferment Filtrate (Sake), Dipropylene Glycol, Aspalathus Linearis Leaf Extract, Lactobacillus/Rice Ferment Filtrate, Saccharomyces/Camellia Sinensis Extract Ferment Filtrate, Propylene Glycol, Sodium Palmitoyl Proline, Rose Flower Oil, Averrhoa Carambola Fruit Extract, Lactobacillus Ferment, Echium Plantagineum Seed Oil, Nymphaea Alba Flower Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, 1,2-Hexanediol, Lactobacillus Ferment Filtrate, Lepidium Meyenii Root Extract, Mannitol, Vanilla Tahitensis Fruit Extract, Royal Jelly Extract, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Magnolia Biondii Flower Extract, Salvia Officinalis (Sage) Leaf Extract, Sodium Benzoate, Ethylhexylglycerin, Benzyl Alcohol, Chrysanthemum Boreale Flower Extract, Citric Acid, Potassium Sorbate, Tocopherol, Limonia Acidissima Extract, , Acetyl Hexapeptide-8, Dehydroacetic Acid, Hydrolyzed Coral, sh-Decapeptide-7, sh-Octapeptide-4, sh-Oligopeptide-9, sh-Pentapeptide-19, sh-Oligopeptide-1

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep out of reach of children.

DESCRIPTION

Uses: Helpe sunscreen agent skin

Directions: Apply liberally and uniformly to all exposed areas before sun exposure. Reapply often(every 2hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection

QUESTIONS

Questions:

TEL,+82-539-3450

www.ultravcosmetic.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA V IDEBENONE SUNBLOCK 
homosalate, avobenzone, ensulizole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71975-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	5.00 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.75 g  in 50 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	1.75 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71975-070-02	1 in 1 CARTON	01/02/2018
1	NDC: 71975-070-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/02/2018

Labeler - Ultra V Co., Ltd (689004748)

Registrant - Ultra V Co., Ltd (689004748)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(71975-070)