ULTRA V IDEBENONE SUNBLOCK- homosalate, avobenzone, ensulizole cream 
Ultra V Co., Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Image of cartonImage of carton

ULTRA V IDEBENONE SUNBLOCK 
homosalate, avobenzone, ensulizole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71975-070
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate5.00 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.75 g  in 50 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE1.75 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71975-070-021 in 1 CARTON01/02/201802/01/2019
1NDC:71975-070-0150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/02/201802/01/2019
Labeler - Ultra V Co., Ltd (689004748)
Registrant - Ultra V Co., Ltd (689004748)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(71975-070)

Revised: 6/2023
 
Ultra V Co., Ltd