NDC | 60565-050-01 |
Set ID | 7970f5ca-a23a-43f4-b571-f860eac5ddab |
Category | HUMAN OTC DRUG LABEL |
Packager | DN Company Co., Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
-
INACTIVE INGREDIENT
Inactive Ingredients:
Water, Ethylhexyl Palmitate, Cyclopentasiloxane,4-Methylbenzylidene Camphor, Butylene Glycol, Butyl Methoxydibenzoylmethane, Dipropylene Glycol, Cetearyl Alcohol, Beeswax, Glyceryl Stearate, Polysorbate 60, PEG-100 Stearate, Glycol Stearate, Triceteareth-4 Phosphate, Silica, Potassium Cetyl Phosphate, Methyl Methacrylate Crosspolymer, Isoamyl Laurate, PEG-2 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glyceryl Caprylate, Caprylyl Glycol, Dimethicone, Caprylic/Capric Triglyceride, Saccharide Isomerate, Hydrogenated Lecithin, Sodium Ascorbyl Phosphate, sh-Oligopeptide-1, Alcohol Denat., Xanthan Gum, BHT, Disodium EDTA, Phenoxyethanol, Fragrance(Parfum) - PURPOSE
-
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
-
INGREDIENTS AND APPEARANCE
EASYDEW EX FRESH MILD SUNSCREEN SPF50 PLUS PA PLUS PLUS PLUS
octinoxate, titanium dioxide, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60565-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 3 mg in 40 mL Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 1.7 mg in 40 mL Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 0.8 mg in 40 mL Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 0.8 mg in 40 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Ethylhexyl Palmitate (UNII: 2865993309) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60565-050-01 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(60565-050)