TONYMOLY MY SUNNY PERFECTING SUN BLOCK- octinoxate, titanium dioxide, octisalate cream

TONYMOLY My Sunny Perfecting Sun Block by

Drug Labeling and Warnings

TONYMOLY My Sunny Perfecting Sun Block by is a Otc medication manufactured, distributed, or labeled by TONYMOLY CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

TONYMOLY MY SUNNY PERFECTING SUN BLOCK 
octinoxate, titanium dioxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59078-047
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.25 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59078-047-01	100 mL in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2014

Labeler - TONYMOLY CO., LTD. (688216798)

Registrant - TONYMOLY CO., LTD. (688216798)

Establishment
Name	Address	ID/FEI	Business Operations
TONYMOLY CO., LTD.		688216798	manufacture(59078-047)