TONYMOLY BCDATION 02- titanium dioxide, zinc oxide cream 
TONY MOLY 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 10.44%, Zinc Oxide 1.44%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cyclopentasiloxane, Butylene Glycol, Phenyl Trimethicone, Hydrogenated Polydecene, Dipropylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Ethylhexyl Olivate, Cyclohexasiloxane, Sodium Chloride, Niacinamide, Orbignya Oleifera Seed Oil, Butylene Glycol Dicaprylate/Dicaprate, Polyglyceryl-4 Isostearate, Methyl Hydrogenated Rosinate, Talc, Iron Oxides (CI 77492), Hexyl Laurate, Disteardimonium Hectorite, Glyceryl Polymethacrylate, Calcium Stearate, Hydrogenated Vegetable Oil, Cetyl Dimethicone, Phenoxyethanol, Propylene Glycol, Dimethicone, Iron Oxides (CI 77491), Glycerin, Caprylyl Glycol, Triethyl Citrate, Iron Oxides (CI 77499), Fragrance, Gelatin, Acacia Senegal Gum, Triethoxycaprylylsilane, Sorbitan Olivate, Sorbitan Isostearate, Pentylene Glycol, Ethylhexylglycerin, Hydrogen Dimethicone, Alcohol, Citrus Grandis (Grapefruit) Peel Oil, 1,2-Hexanediol, Adenosine, Disodium EDTA, Sodium Hyaluronate, Oxygen, Pinus Densiflora Extract, Olea Europaea (Olive) Fruit Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Moringa Oleifera Seed Oil, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Betula Platyphylla Japonica Juice, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Imperata Cylindrica Root Extract, Pseudoalteromonas Ferment Extract, Argania Spinosa Kernel Oil, Adansonia Digitata Seed Oil, PEG-8, Phaseolus Radiatus Seed Extract, Silica Dimethyl Silylate, Carbomer, Avena Sativa (Oat) Meal Extract, Tocopherol, Hexylene Glycol, Acetyl Heptapeptide-9, Colloidal Gold

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 babies and children

INDICATIONS & USAGE

Indication and usage: After basic skin care, dispense a pearl amount of CC cream and evenly apply from cheeks, forehead, nose to chin. To conceal imperfections better, you can reapply.

DOSAGE & ADMINISTRATION

Dosage and administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

TONYMOLY BCDATION  02
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-049
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide5.22 g  in 50 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.72 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-049-0150 g in 1 CARTON; Type 0: Not a Combination Product05/01/201411/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/201411/30/2015
Labeler - TONY MOLY CO.,LTD (688216798)
Registrant - TONY MOLY CO.,LTD (688216798)
Establishment
NameAddressID/FEIBusiness Operations
Cosmecca Korea Co., Ltd.688830827manufacture(59078-049)

Revised: 12/2018
 
TONY MOLY CO.,LTD