Label: INTENSE CARE GOLD 24K SNAIL SUN- homosalate, octisalate, ensulizole, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59078-325-01, 59078-325-02 - Packager: TONYMOLY CO.,LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated August 31, 2017
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- ACTIVE INGREDIENT
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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
- WARNINGS
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INTENSE CARE GOLD 24K SNAIL SUN
homosalate, octisalate, ensulizole, octocrylene creamProduct 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)