Label: MIZON UV SUN PROTECTOR- octinoxate, octisalate, zinc oxide, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 57718-070-01 - Packager: MIZON CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 January 8, 2016
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Water, Cyclopentasiloxane, Cyclohexasiloxane, Butylene Glycol, Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone, Silica, Dimethicone/Vinyl Dimethicone Crosspolymer, Triethyl Citrate, Sodium Chloride, DIMETHICONE/PEG-10/15 CROSSPOLYMER, Triethoxycaprylylsilane, Sodium Hyaluronate, Biosaccharide Gum-1, Hedera Helix(Ivy) Extract, Ethylhexylglycerin, Caprylyl Glycol, Disteardimonium Hectorite, Brassica Oleracea Italica(Broccoli) Extract, Fragrance, Allantoin, Sodium Citrate, Tropolone, Argania Spinosa Kernel Oil, Dipropylene Glycol, Disodium Edta, Tocopherol
- PURPOSE
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WARNINGS
Warnings: 1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itching, irritation, or symptoms where product has been applied under direct sunlight. 2. Do not use on scarred skin or if you have dermatitis or eczema. 3. Keep the cap closed on this product. 4. Keep away from direct sunlight or heat. 5. Keep out of reach of children.
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MIZON UV SUN PROTECTOR
octinoxate, octisalate, zinc oxide, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57718-070 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 3.67 g in 50 mL Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 2.37 g in 50 mL Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 2.15 g in 50 mL Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 1.80 g in 50 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57718-070-01 50 mL in 1 CARTON; 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 12/01/2015 Labeler - MIZON CO., LTD. (557815570) Registrant - MIZON CO., LTD. (557815570) Establishment Name Address ID/FEI Business Operations MIZON CO., LTD. 557815570 repack(57718-070) Establishment Name Address ID/FEI Business Operations Coson Co., Ltd. 689835593 manufacture(57718-070)