MY SUNNY WATERY SUN ESSENCE- octinoxate, homosalate, octisalate, octocrylene cream

MY SUNNY WATERY SUN ESSENCE by

Drug Labeling and Warnings

MY SUNNY WATERY SUN ESSENCE by is a Otc medication manufactured, distributed, or labeled by TONYMOLY CO.,LTD, Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: ETHYLHEXYL METHOXYCINNAMATE 6.80%, HOMOSALATE 6.00%, ETHYLHEXYL SALICYLATE 4.50%, OCTOCRYLENE 2.50%

INACTIVE INGREDIENT

Inactive ingredients: Water, Butylene Glycol, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Polymethyl Methacrylate, 1,2-Hexanediol, Cyclopentasiloxane, Propanediol, Phenoxyethanol, Octyldodecanol, Saccharide Hydrolysate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Fragrance, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Carbomer, Tromethamine, Polyacrylate Crosspolymer-6, Echium Plantagineum Seed Oil, Isohexadecane, Portulaca Oleracea Extract, Curcuma Longa (Turmeric) Root Extract, Centella Asiatica Extract, Salvia Hispanica Seed Extract, Sodium Hyaluronate, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Ethylhexylglycerin, t-Butyl Alcohol, Soluble Collagen, Xanthan Gum, Glycyrrhiza Glabra (Licorice) Root Extract, Aloe Barbadensis Leaf Juice, Paeonia Lactiflora Root Extract, Cnidium Officinale Root Extract, Pueraria Thunbergiana Root Extract, Tocopherol, Silica, Hydrolyzed Hyaluronic Acid, Glyceryl Caprylate, Niacinamide, Sodium Starch Octenylsuccinate, Calcium Pantothenate, Maltodextrin, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Pyridoxine HCL, Nymphaba Alba Flower Extract

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only Do not use on damaged or broken skin Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use.

Keep Out of Reach of Children

DESCRIPTION

Uses: Helps prevent sunburn

Directions: Apply liberally 15 minutes before sun exposure - Reapply at least every 2 hours - Children under 6 months: Ask a doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MY SUNNY WATERY SUN ESSENCE 
octinoxate, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59078-324
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.4 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3.0 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.25 g  in 50 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59078-324-02	1 in 1 CARTON	06/01/2017
1	NDC: 59078-324-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2017

Labeler - TONYMOLY CO.,LTD (688216798)

Registrant - TONYMOLY CO.,LTD (688216798)

Establishment
Name	Address	ID/FEI	Business Operations
TONYMOLY CO.,LTD		688216798	relabel(59078-324)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(59078-324)