SUPREME SKINPIA 10 SUN BLOCK- octinoxate, zinc oxide, titanium dioxide cream 
EBAIN Corporation 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%, Zinc Oxide 3%, Titanium Dioxide 3%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Cyclopentasiloxane, Cyclomethicone, Propylene Glycol, Glycerin, Dimethicone, Isononyl Isononanoate, 4-Methylbenzylidene Camphor, PEG-10 Dimethicone, Polymethyl Methacrylate, 1,2-Hexanediol, Triethanolamine, Sorbitan Sesquioleate, Magnesium Sulfate,
Disteardimonium Hectorite, Stearic Acid, Aluminum Hydroxide, Betaine, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Allantoin, Saccharomyces/Viscum Album (Mistletoe) Ferment Extract, Lactobacillus/Soybean Ferment Extract, Saccharomyces/Imperata Cylindrica Root Ferment Extract, Aloe Barbadensis Leaf Juice Powder, Dipotassium Glycyrrhizate, Butylene Glycol, Larix Sibirica Wood Extract, Chrysanthellum Indicum Extract, Rheum Palmatum Root/Stalk Extract, Asarum Sieboldi Root Extract, Quercus Mongolia Leaf Extract , Persicaria Hydropiper Extract, Illicium Verum (Anise) Fruit Extract, Corydalis Turtschaninovii Root Extract, Coptis Japonica Root Extract, Machilus Thunbergii Bark Extract, Sarcodon Aspratus Extract, Lepidium Meyenii Root Extract, Ethylhexylglycerin, Portulaca Oleracea Extract, Fomes Officinalis (Mushroom) Extract, PEG-40 Hydrogenated Castor Oil, Sodium Hyaluronate, Polyglutamic Acid

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:
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.
- In case of haviong problems such as red rash, swollenness, itching, stimulation during usage.
- 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 children: Keep out of reach of babies and children

INDICATIONS AND USAGE

Indications and usage: After basic skin care, apply adequate amount following the skin texture and gently tap to enhance absorption.

DOSAGE AND ADMINISTRATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

SUPREME SKINPIA 10 SUN BLOCK 
octinoxate, zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62242-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.5 mg  in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.5 mg  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.5 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62242-010-0150 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/02/2014
Labeler - EBAIN Corporation Co., Ltd. (689048989)
Registrant - EBAIN Corporation Co., Ltd. (689048989)
Establishment
NameAddressID/FEIBusiness Operations
EBAIN Corporation Co., Ltd.689048989manufacture(62242-010)

Revised: 3/2014
Document Id: f90efcb7-86bf-4126-8de3-f4de8e6b3157
Set id: 9a824803-cd98-4b66-bb3e-eb406103ae75
Version: 1
Effective Time: 20140304
 
EBAIN Corporation Co., Ltd.