Label: DR MEDECEAN RISING SUN COVER- octinoxate, titanium dioxide, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70540-040-01, 70540-040-02 - Packager: INNOGENE 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 September 27, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients: Water, Butylene Glycol, Dibutyl Adipate, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Pentylene Glycol, Glycerin, Cyclopentasiloxane, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cyclohexasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Arachidyl Alcohol, Polysorbate 60, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate, Allantoin, Oleth-10, Behenyl Alcohol, Aluminum Hydroxide, Triethoxycaprylylsilane, Mannitol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Arachidyl Glucoside, 1,2-Hexanediol, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ammonium Glycyrrhizate, Triethanolamine, Coco-glucoside, Citric acid, Adenosine, Disodium EDTA, Laureth-4, Caffeine, Zinc Gluconate, BHT, Sorbic Acid, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Acetyl Tetrapeptide-15
- PURPOSE
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WARNINGS
Warnings: For external use only
1. If the Red swellings such as erythema, itchiness, or irritations because of directly sunlight occur, you must stop using immediately and Consult your dermatologist. 2. Do not apply on skin conditions such as wounds. 3. Storage and Handling. a. Keep out of the reach of children. b. Avoid direct sunlight.
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR MEDECEAN RISING SUN COVER
octinoxate, titanium dioxide, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70540-040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 4.0 g in 50 g Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 1.5 g in 50 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 1.0 g in 50 g 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:70540-040-02 1 in 1 CARTON 09/01/2017 1 NDC:70540-040-01 50 g 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 09/01/2017 Labeler - INNOGENE CO.,LTD (688201056) Registrant - INNOGENE CO.,LTD (688201056) Establishment Name Address ID/FEI Business Operations INNOGENE CO.,LTD 688201056 manufacture(70540-040)
