RORIS SHINY CC SPF37 PA PLUS PLUS PLUS- titanium dioxide, zinc oxide, ethylhexyl methoxycinnamate cream 
ZION SYNTHETIC FIBER 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, Zinc Oxide, Ethylhexyl Methoxycinnamate

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Butylene Glycol, Cyclopentasiloxane-Cyclohexasiloxane, Phenyl Trimethicone, Cetyl Ethylhexanoate, Glycerin, Synthetic Fluorphlogopite, Tin Oxide, Cetyl PEG/PPG-10/1, Dimethicone, 4-Methylbenzylidene Camphor, Polymethylmethacrylate, Betaine,
Sodium Chloride, Silica, Dimehicone/Vinyl Dimethicone Crosspolymer, Bees Wax, Sorbitan Olivate, Polyglyceryl-4-Isostearate, Alpha-Bisabolol, Disteardimonium Hectorite, Dimethicone, Aluminum Hydroxide, Iron oxide(C177492), Stearic Acid, Phenoxyethanol,
Portulaca Oleacea Extract, Caprylic Capric Triglyceide, Hydrogenated Lecithin, Iron oxide, (C177491), Iron oxide(C177499), Tocopheryl Acetate, Triethoxy Caprylylsilane, Camellia, Japonica Seed Oil, Allantoin, Adenosine, Camellia Sinensis (Green Tea) Leaf Extract,
Rosmarinus Officinalis (Rosemary) Leaf Extract, Hamamelis Virginiana (Witch Hazel) Extract, Acetyl Hexapeptide-8, Ceramide 3, Disodium EDTA, Aloe Ferox Leaf Extract, Aesculus Hippocastanum (Horse Chestnut) Extract, Sodium Hyaluronate, Tourmaline,
Zeolite, Hematite Extract, Biotite, Illite, Olivine Extract, Topaz, Flavor

PURPOSE

Purpose:
Protects your skin from Ultra-violet Rays.
Anti-wrinkle and Whitening
It soothes the sensitive skin, and delivers the moisture.

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.
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 children:
Keep out of the reach of babies and children.

INDICATIONS AND USAGE

Indications and Usage:
1. Tighten the lid after using it.
2. Don't keep it in the place where the temperature is extremely hot or low and exposed the direct sunlight.
3. Please apply it an adequate quantity evenly on face and throat at the last stage of basic makeup.

DOSAGE AND ADMINISTRATION

Dosage and Administration:
Take up about 1.2g of it and smooth over the entire face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

RORIS SHINY CC  SPF37 PA PLUS PLUS PLUS
titanium dioxide, zinc oxide, ethylhexyl methoxycinnamate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44781-220
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide4.87 g  in 50 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 g  in 50 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.5 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44781-220-0150 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2013
Labeler - ZION SYNTHETIC FIBER CO., LTD. (688011147)
Registrant - ZION SYNTHETIC FIBER CO., LTD. (688011147)
Establishment
NameAddressID/FEIBusiness Operations
ZION SYNTHETIC FIBER CO., LTD.688011147manufacture(44781-220)

Revised: 5/2013
Document Id: e8c2593f-791d-4a03-b7ba-f86f17ef1851
Set id: 2b95d1db-bd85-4e21-b2eb-ebf9b0104523
Version: 1
Effective Time: 20130506
 
ZION SYNTHETIC FIBER CO., LTD.