TONYMOLY Timeless Ferment Snail Cream: Package Insert and Label Information

TONYMOLY TIMELESS FERMENT SNAIL CREAM- glycerin 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.

Glycerin 7.79415%

Purpose

Skin Protectant

Dosage

Apply a small amount of this product.

Caution

For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

Keep out of reach of children

Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

Directions

Dispense Ampoule Cream and Emulsified Cream in an appropriate ratio. Evenly apply to the skin and gently pat for absorption.

After essence, apply evenly across the face.

Inactive Ingredients

Octyldodecyl Myristate, Macadamia Ternifolia Seed Oil, Caprylic/Capric Triglyceride, Butyrospermum Parkii (Shea) Butter, Dimethicone, Glycol Stearate SE, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Stearate, Limnanthes Alba (Meadowfoam) Seed Oil, Hydrogenated Vegetable Oil, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Water, PEG-100 Stearate, Isohexadecane, Beeswax, Palmitic Acid, Phenoxyethanol, Carbomer, Polysorbate 80, Chlorphenesin, Stearic Acid, Hydrogenated Lecithin, Tromethamine, Polyacrylate-13, Ethylhexylglycerin, Caprylyl Glycol, Tocopheryl Acetate, Polyisobutene, Laureth-23, Citrus Limon (Lemon) Peel Oil, Adenosine, Phenyl Trimethicone, Disodium EDTA, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Alcohol, Sorbitan Isostearate, Polysorbate 20, Citrus aurantium dulcis (orange) peel oil, Glyceryl Acrylate/Acrylic Acid Copolymer, Chamaecyparis Obtusa Water, Citrus Aurantifolia (Lime) Oil, Pinus Sylvestris Leaf Oil, Imperata Cylindrica Root Extract, Sodium Hyaluronate, Opuntia Ficus-Indica Extract, Eucalyptus Globulus Leaf Oil, Propanediol, PEG-8, Centella Asiatica Extract, Carica papaya (papaya) fruit Extract, Aloe Barbadensis Leaf Juice, Beta-Glucan, Citric Acid, Potassium sorbate, Sodium Benzoate

Principal Display Panel

Established Pharmacological Class

Substance Pharmacological Class TONYMOLY Timeless Ferment Snail Cream Other Skin Care Preparations

TONYMOLY TIMELESS FERMENT SNAIL CREAM glycerin cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59078-103 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (GLYCERIN) GLYCERIN 4910.1 mg in 50 mL

Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE MEADOWFOAM SEED OIL LEMON PEEL EDETATE DISODIUM BERGAMOT OIL GLYCIDYL ACRYLATE ORANGE PEEL CHAMAECYPARIS OBTUSA WHOLE LIME OIL PINE NEEDLE OIL (PINUS SYLVESTRIS) IMPERATA CYLINDRICA ROOT HYALURONATE SODIUM EUCALYPTUS GLOBULUS LEAF PAPAYA CETYL ETHYLHEXANOATE BUTYLENE GLYCOL HYDROGENATED POLYDECENE (550 MW) OCTYLDODECYL MYRISTATE DIMETHICONE POLYSORBATE 80 ETHYLHEXYLGLYCERIN CAPRYLYL GLYCOL LAURETH-23 ADENOSINE SORBITAN ISOSTEARATE POLYSORBATE 20 PROPANEDIOL NIACINAMIDE SODIUM BENZOATE WATER PEG-100 STEARATE ISOHEXADECANE PALMITIC ACID PHENOXYETHANOL CHLORPHENESIN STEARIC ACID SHEA BUTTER GLYCERYL STEARATE SE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) SODIUM ACRYLATE YELLOW WAX HYDROGENATED SOYBEAN LECITHIN OPUNTIA FICUS-INDICA POLYETHYLENE GLYCOL 400 CENTELLA ASIATICA ALOE VERA LEAF

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:59078-103-02 1 BOTTLE in 1 CARTON contains a BOTTLE 1 50 mL in 1 BOTTLE This package is contained within the CARTON (59078-103-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 01/10/2016

Labeler — Tonymoly Co., Ltd. (688216798)

Registrant — Tonymoly Co., Ltd. (688216798)

Establishment
Name	Address	ID/FEI	Operations
Cosmecca		688830827	manufacture (59078-103)

Revised: 02/2016 Tonymoly Co., Ltd.