Label: SNAIL REPAIR BLEMISH BALM- octinoxate, titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62171-030-01 - Packager: Coson 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 April 17, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients:
SNAIL SECRETION FILTRATE, CYCLOPENTASILOXANE, POLYMETHYL METHACRYLATE, PEG/PPG-17/6 COPOLYMER, DICAPRYLYL CARBONATE, DIMETHICONE, CETYL PEG/PPG-10/1 DIMETHICONE, ARBUTINE, SODIUMCHLORIDE, OZOKERITE, CYCLOPENTASILOXANE, TRIETHYL CITRATE,DISTEARDIMONIUM HECTORITE,GLYCOSYLTREHALOSE,HYDROGENATED STARCH HYDROLYSATE,CALCIUM STEARATE,HEXYL LAURATE, SORBITAN SESQUIOLEATE,SODIUM HYALURONATE,LAURYLPEG/PPG-18/18 METHICONE,SORBITAN SESQUIOLEATE,ALLANTOIN,PANTHENOL,BETA-GLUCAN,ADENOSINE,LECITHIN,TOCOPHERYL ACETATE ,CAPRYLIC/CAPRIC TRIGLYCERIDE,UBIQUINONE ,DIISOPROPYL ADIPATE,GLYCERIN,ARNICA MONTANA FLOWER EXTRACT,ARTEMISIA ABSINTHIUM EXTRACT,ACHILLEA MILLEFOLIUM EXTRACT ,GENTIANA LUTEA ROOT EXTRACT ,ETHANOL,CASTANEA SATIVA(CHESTNUT) SEED EXTRACT,CARICA PAPAYA(PAPAYA) FRUIT EXTRACT,LAVANDULA ANGUSTIFOLIA(LAVENDER)EXTRACT,CORNUSOFFICINALIS FRUIT EXTRACT,CAPRYLYL GLYCOL,ETHYLHEXYLGLYCERIN,TROPOLONE,DISODIUM EDTA,FRAGRANCE,CI 77491 ,CI 77492 ,CI 77499 - PURPOSE
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WARNINGS
Warnings:
1. If following symptoms occur, stop use and consult a doctor : red spots, swelling, itcihng, irritation, or symtoms on applied skin under direct sunlight.
2. Do not use on scarred skin, or if you have dermatitis or eczema
3. Keep the cap close on its product
4. Keep away from direct sunlight or heat.
5. This product blocks UVA rays and ultraviolet protection effectiveness have been measured by the Food and Drug Administration methods and standards - KEEP OUT OF REACH OF CHILDREN
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SNAIL REPAIR BLEMISH BALM
octinoxate, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62171-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.82 mg in 50 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.49 mg in 50 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.38 mg in 50 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62171-030-01 50 mL in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2014 Labeler - Coson Co., Ltd. (689835593) Registrant - Coson Co., Ltd. (689835593) Establishment Name Address ID/FEI Business Operations Coson Co., Ltd. 689835593 manufacture(62171-030)
