INTENSE CARE GOLD 24K SNAIL SUN- homosalate, octisalate, ensulizole, octocrylene cream

INTENSE CARE GOLD 24K SNAIL SUN by

Drug Labeling and Warnings

INTENSE CARE GOLD 24K SNAIL SUN by is a Otc medication manufactured, distributed, or labeled by TONYMOLY CO.,LTD, Cosmecca Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

INTENSE CARE GOLD 24K SNAIL SUN 
homosalate, octisalate, ensulizole, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59078-325
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	3.50 g  in 50 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	2.25 g  in 50 mL
Ensulizole (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	Ensulizole	1.50 g  in 50 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	0.50 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59078-325-02	1 in 1 CARTON	08/01/2017
1	NDC: 59078-325-01	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	08/01/2017

Labeler - TONYMOLY CO.,LTD (688216798)

Registrant - TONYMOLY CO.,LTD (688216798)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmecca Korea Co., Ltd.		688830827	manufacture(59078-325)