TONYMOLY INTENSE CARE SNAIL BB- titanium dioxide, zinc oxide 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: 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 cartonImage of carton

TONYMOLY INTENSE CARE SNAIL BB 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide4.50 mg  in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3.15 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Butylene Glycol (UNII: 3XUS85K0RA)  
Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-051-0150 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2015
Labeler - Tonymoly Co., Ltd. (688216798)
Registrant - Tonymoly Co., Ltd. (688216798)
Establishment
NameAddressID/FEIBusiness Operations
Tonymoly Co., Ltd.688216798repack(59078-051)
Establishment
NameAddressID/FEIBusiness Operations
Cosmecca Korea Co.,Ltd.688830827manufacture(59078-051)

Revised: 3/2015
Document Id: a9c482a2-553b-491c-b76c-419e3ab9198c
Set id: 5019abfb-9f92-4360-ab0d-42a6d766c23f
Version: 1
Effective Time: 20150303
 
Tonymoly Co., Ltd.