Label: TONYMOLY INTENSE CARE SNAIL BB- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59078-051-01 - 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 March 3, 2015
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- ACTIVE INGREDIENT
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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
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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
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TONYMOLY INTENSE CARE SNAIL BB
titanium dioxide, zinc oxide creamProduct 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)