Label: RORIS SHINY CC SPF37 PA PLUS PLUS PLUS- titanium dioxide, zinc oxide, ethylhexyl methoxycinnamate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 44781-220-01 - Packager: ZION SYNTHETIC FIBER CO., LTD.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated May 6, 2013
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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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
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RORIS SHINY CC SPF37 PA PLUS PLUS PLUS
titanium dioxide, zinc oxide, ethylhexyl methoxycinnamate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44781-220 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 4.87 g in 50 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.75 g in 50 g Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 1.5 g in 50 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44781-220-01 50 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2013 Labeler - ZION SYNTHETIC FIBER CO., LTD. (688011147) Registrant - ZION SYNTHETIC FIBER CO., LTD. (688011147) Establishment Name Address ID/FEI Business Operations ZION SYNTHETIC FIBER CO., LTD. 688011147 manufacture(44781-220)
