Label: MIZON SNAIL REPAIR INTENSIVE BB 23- octinoxate, titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 57718-400-01, 57718-400-02 - 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 20, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
Snail Secretion Filtrate, Cyclopentasiloxane, Glycerin, Diisostearyl Malate, Phenyl Trimethicone, Cyclohexasiloxane, Methyl Methacrylate Crosspolymer, PEG-10 Dimethicone, Niacinamide, Cyclomethicone, Sodium Chloride, Trimethylsiloxyphenyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium Hectorite, Sorbitan Sesquioleate, Polyethylene, Triethoxycaprylylsilane, Dimethicone Crosspolymer, Aluminum Hydroxide, Ethylhexylglycerin, Adenosine, Disodium EDTA, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499), Phenoxyethanol - PURPOSE
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WARNINGS
Warnings:
1)In case of swelling, redness, itching or any severe allergic reactions while using the product, discontinue use and consult with a specialist.
2) Do not apply on broken skin or wounded areas.
3) Precautions for storage and handling
A) Keep out of reach of children.
B) Store away from direct sunlight. - DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MIZON SNAIL REPAIR INTENSIVE BB 23
octinoxate, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57718-400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 3.50 g in 50 mL Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 4.41 g in 50 mL Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 2.00 g in 50 mL Inactive Ingredients Ingredient Name Strength Glycerin (UNII: PDC6A3C0OX) Diisostearyl Malate (UNII: QBS8A3XZGQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57718-400-02 1 in 1 CARTON 12/01/2019 1 NDC:57718-400-01 50 mL in 1 CONTAINER; 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 12/01/2019 Labeler - MIZON CO.,LTD. (694894201) Registrant - PFD Co.,Ltd. (694522499) Establishment Name Address ID/FEI Business Operations COSON Co., Ltd._Osan Plant 689847210 manufacture(57718-400)