TONYMOLY INTENSE CARE SNAIL BB- titanium dioxide, zinc oxide cream

TONYMOLY INTENSE CARE SNAIL BB by

Drug Labeling and Warnings

TONYMOLY INTENSE CARE SNAIL BB 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: Titanium Dioxide 9.01%, Zinc Oxide 6.30%

INACTIVE INGREDIENT

Inactive Ingredients: Snail Secretion Filtrate, Butylene Glycol, Phenyl Trimethicone, Dimethicone, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Butylene Glycol Dicaprylate/Dicaprate, Orbignya Oleifera Seed Oil, Cetyl PEG/PPG-10/1 Dimethicone, Arbutin, Magnesium Sulfate, Aluminum Hydroxide, Stearic Acid, Iron Oxides (CI 77492), Water, Caprylyl Glycol, Polyglyceryl-4 Isostearate, Hexyl Laurate, Triethoxycaprylylsilane, Phenoxyethanol, Ethylhexylglycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, Talc, Iron Oxides (CI 77499), Iron Oxides (CI 77491), Tocopheryl Acetate, Sorbitan Isostearate, Rosa Canina Fruit Oil, Calcium Stearate, 1,2-Hexanediol, Glycerin, Imperata Cylindrica Root Extract, Adenosine, Disodium EDTA, Citrus Medica Limonum (Lemon) Peel Oil, Camellia Sinensis Callus Culture Extract, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Oryza Sativa (Rice) Callus Culture Extract, Leontopodium Alpinum Callus Culture Extract, PEG-8, Citrus aurantium dulcis (orange) peel oil, Steareth-20, Citrus Aurantifolia (Lime) Oil, Pinus Sylvestris Leaf Oil, Eucalyptus Globulus Leaf Oil, Centella Asiatica Extract, Carbomer, Aloe Barbadensis Leaf Juice, Usnea Barbata (Lichen) Extract, Zanthoxylum Piperitum Fruit Extract, Xanthan Gum, Pulsatilla Koreana Extract, N-Hydroxysuccinimide, Potassium sorbate, Sodium Hyaluronate, Lecithin, Sodium Benzoate, Acetyl Hexapeptide-8, Palmitoyl Oligopeptide, Chrysin, Palmitoyl Tetrapeptide-7, Chlorhexidine digluconate

PURPOSE

Purpose: Sunscreen

WARNINGS

Warning: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of Children: Keep out of reach of babies and children

INDICATIONS & USAGE

Indication & Usage: After application of skin care products, apply on face using fingers or sponge.

DOSAGE & ADMINISTRATION

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

INGREDIENTS AND APPEARANCE

TONYMOLY INTENSE CARE SNAIL BB 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59078-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	4.50 mg  in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	3.15 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Butylene Glycol (UNII: 3XUS85K0RA)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59078-051-01	50 mL in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2015

Labeler - Tonymoly Co., Ltd. (688216798)

Registrant - Tonymoly Co., Ltd. (688216798)

Establishment
Name	Address	ID/FEI	Business Operations
Tonymoly Co., Ltd.		688216798	repack(59078-051)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmecca Korea Co.,Ltd.		688830827	manufacture(59078-051)