TONYMOLY MY SUNNY PERFECTING SUN BLOCK- octinoxate, titanium dioxide, octisalate 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: Ethylhexyl Methoxycinnamate 7.5%, Titanium Dioxide 4.25%, Ethylhexyl Salicylate 2%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Glycerin, Ethylhexyl Palmitate, Cyclopentasiloxane, 4-Methylbenzylidene Camphor, Butyl Methoxydibenzoylmethane, Octocrylene, Cyclohexasiloxane, Silica, Aloe Barbadensis Leaf Juice, Lavandula Angustifolia (Lavender) Water, Anthemis Nobilis Flower Water, Prunus Mume Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Codium Tomentosum Extract, Enteromorpha Compressa Extract, Macrocystis Pyrifera (Kelp) Extract, Ecklonia Cava Extract, Gelidium Cartilagineum Extract, Laminaria Japonica Extract, Nymphaea Alba Flower Extract, Chamaecyparis Obtusa Leaf Extract, Viscum Album (Mistletoe) Fruit Extract, Sansevieria Trifasciata Leaf Extract, Portulaca Oleracea Extract, Glyceryl Stearate, PEG-100 Stearate, Triceteareth-4 Phosphate, Glycol Stearate, Sorbitan Sesquioleate, Potassium Cetyl Phosphate, PEG-2 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Caprylate, Bis-Diglyceryl Polyacyladipate-2, Tromethamine, Caprylyl Glycol, Dimethicone, Butylene Glycol, Polydecene, Dipropylene Glycol, Sodium Palmitoyl Proline, Squalane, Coco-Glucoside, Sorbic Acid, Ethylhexylglycerin, Acetyl Tetrapeptide-15, Cetearyl Alcohol, Xanthan Gum, Disodium EDTA, Phenoxyethanol, Benzyl Alcohol, Potassium Sorbate, Dehydroacetic Acid, Sodium Benzoate, Fragrance(Parfum)

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 AND USAGE

Indications and usage:
Take one pearl size amount on cheeks, forehead and chin and spread following the skin texture.

DOSAGE AND ADMINISTRATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

TONYMOLY MY SUNNY PERFECTING SUN BLOCK 
octinoxate, titanium dioxide, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-047
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.25 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-047-01100 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2014
Labeler - TONYMOLY CO., LTD. (688216798)
Registrant - TONYMOLY CO., LTD. (688216798)
Establishment
NameAddressID/FEIBusiness Operations
TONYMOLY CO., LTD.688216798manufacture(59078-047)

Revised: 6/2014
Document Id: 286c1ce5-394b-4d36-acdb-83f69225948a
Set id: 883a368f-b56f-44d9-a625-62574ab95bf0
Version: 1
Effective Time: 20140626
 
TONYMOLY CO., LTD.