Label: CLAPIEL DEFENSE SUNBLOCK- octinoxate, zinc oxide, octisalate, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69977-050-01 - Packager: AUS KOREA 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 July 24, 2015
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Water, Cyclopentasiloxane, Dipropylene Glycol, Peg-10 Dimethicone, Dicaprylyl Carbonate, Niacinamide, Disteardimonium Hectorite, Dimethicone, Magnesium Sulfate, Aluminum Hydroxide, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Phenoxyethanol, Viscum Album (Mistletoe) Leaf Extract, Centella Asiatica Extract, Portulaca Oleracea Extract, Stearic Acid, Fragrance, Polymethylsilsesquioxane, Methicone, Caprylyl Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG-9 Plydimethylsiloxyethyl Dimethicone, Actinidia Chinensis (Kiwi) Fruit Extract, Camellia Sinensis Callus Culture Extract, Cucurbita Pepo (Pumpkin) Fruit Extract, Daucus Carota Sativa (Carrot) Root Extract, Glyceryl Caprylate, Mangifera Indica (Mango) Fruit Extract, Polyglyceryl-6 Plyricinoleate, Tocopheryl Acetate, Sodium Hyaluronate
- 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: Keep out of reach of babies and children
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLAPIEL DEFENSE SUNBLOCK
octinoxate, zinc oxide, octisalate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69977-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.4 mg in 50 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 2.5 mg in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.25 mg in 50 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.0 mg in 50 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Dipropylene Glycol (UNII: E107L85C40) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69977-050-01 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 05/01/2015 Labeler - AUS KOREA CO., LTD. (689515251) Registrant - AUS KOREA CO., LTD. (689515251) Establishment Name Address ID/FEI Business Operations AUS KOREA CO., LTD. 689515251 manufacture(69977-050)
