INTENSE CARE GOLD 24K SNAIL SUN- homosalate, octisalate, ensulizole, octocrylene cream 
TONYMOLY 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 7.0%, Ethylhexyl Salicylate 4.5%, Phenylbenzimidazole Sulfonic Acid 3.0%, Octocrylene 1.0%

INACTIVE INGREDIENT

Inactive ingredients: Water, Snail Secretion Filtrate, Butylene Glycol, Methyl Methacrylate Crosspolymer, C12-15 Alkyl Benzoate, Butyl Methoxydibenzoylmethane, Silica, Hydrogenated Polydecene, Niacinamide, Dipropylene Glycol, Glyceryl Stearate, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Polysorbate 60, Dimethicone, Sodium Hydroxide, Caprylyl Glycol, Sorbitan Stearate, Polyacrylate-13, PEG-100 Stearate, Ethylhexylglycerin, Tocopheryl Acetate, Citrus Limon (Lemon) Peel Oil, Polyisobutene, Disodium EDTA, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, BHT, 1,2-Hexanediol, Adenosine, Polysorbate 20, Citrus Aurantium Dulcis (Orange) Peel Oil, Sorbitan Isostearate, Citrus Aurantifolia (Lime) Oil, Pinus Sylvestris Leaf Oil, Chamaecyparis Obtusa Water, Eucalyptus Globulus Leaf Oil, Glycerin, Imperata Cylindrica Root Extract, Propanediol, Panthenol, PEG-8, Phenoxyethanol, Carbomer, Centella Asiatica Extract, Carica Papaya (Papaya) Fruit Extract, Aloe Barbadensis Leaf Juice, Beta-Glucan, Potassium Sorbate, Gold, Sodium Benzoate

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: - Helps prevent sunburn - If used as directed with other sun protection measures

Directions: During the last step of basic skin care, dispense an appropriate amount and evenly apply to any skin that will be exposed to ultraviolet light.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

INTENSE CARE GOLD 24K SNAIL SUN 
homosalate, octisalate, ensulizole, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-325
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate3.50 g  in 50 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate2.25 g  in 50 mL
Ensulizole (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) Ensulizole1.50 g  in 50 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene0.50 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-325-021 in 1 CARTON08/01/2017
1NDC:59078-325-0150 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 finalpart35208/01/2017
Labeler - TONYMOLY CO.,LTD (688216798)
Registrant - TONYMOLY CO.,LTD (688216798)
Establishment
NameAddressID/FEIBusiness Operations
Cosmecca Korea Co., Ltd.688830827manufacture(59078-325)

Revised: 8/2017
Document Id: 42aeea79-4643-4d90-a3aa-e5b5114068aa
Set id: 615fac25-810b-48ca-884f-2ae303a1fa4c
Version: 1
Effective Time: 20170831
 
TONYMOLY CO.,LTD