NDC | 60565-040-01 |
Set ID | 99fe1885-8ef5-4e69-9617-6ffdb01a0c35 |
Category | HUMAN OTC DRUG LABEL |
Packager | DN Company Co., Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients:
Water, Cyclopentasiloxane, Cyclohexasiloxane, Glycerin, PEG-10 Dimethicone, Dicaprylyl Carbonate, Butylene Glycol, Arbutin, Sodium Chloride, Rosa Canina Fruit Oil, Avena Sativa (Oat) Kernel Extract, Amethyst Powder, Pearl Powder, Tourmaline, Brassica Oleracea Italica (Broccoli) Sprout Extract, Zea Mays (Corn) Leaf Extract, Triticum Aestivum (Wheat) Leaf Extract, Hydrolyzed Coral, Phenyl Trimethicone, Methyl Methacrylate Crosspolymer, Disteardimonium Hectorite, Cetyl PEG/PPG-10/1 Dimethicone, Sorbitan Sesquioleate, Isoamyl p-Methoxycinnamate, Dimethicone, Glyceryl Behenate/Eicosadioate, Caprylic/Capric Glycerides, Ethylhexylglycerin, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Adenosine, Hydrogenated Lecithin, Potassium Cetyl Phosphate, Sodium Ascorbyl Phosphate, sh-Oligopeptide-1, Alcohol Denat., BHT, Disodium EDTA, Phenoxyethanol, Fragrance(Parfum), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499) - 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
- In case of having problems such as red rash, swollenness, itching, stimulation during usage.
- 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
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EASYDEW EX MINERAL BB SPF45 PA PLUS PLUS
titanium dioxide, octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60565-040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 3.97 mg in 40 mL Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 2.8 mg in 40 mL Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 1.17 mg in 40 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60565-040-01 40 mL in 1 CARTON; Type 0: Not a Combination Product 07/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/01/2013 Labeler - DN Company Co., Ltd. (688369859) Registrant - DN Company Co., Ltd. (688369859) Establishment Name Address ID/FEI Business Operations Cosmax, Inc. 689049693 manufacture(60565-040)