NDC | 71882-010-01 |
Set ID | 39c34e53-eff3-457e-a021-6d268439a1cd |
Category | HUMAN OTC DRUG LABEL |
Packager | Dermal Korea Co., Ltd |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
-
INACTIVE INGREDIENT
Inactive ingredients: Water, Alcohol Denat., Dipropylene Glycol, Methyl Methacrylate Crosspolymer, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Isoamyl p-Methoxycinnamate, Bis-PEG/PPG-20/5 PEG/PPG-20/5 Dimethicone, Methoxy PEG/PPG-25/4 Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylic/Capric Triglyceride, Dimethicone, Caprylyl Glycol, Fragrance, Sodium Hydroxide, Ethylhexylglycerin, Centella Asiatica Extract, Adansonia Digitata Seed Extract, Aloe Barbadensis Leaf Extract, 1,2-Hexanediol, BHT, Disodium EDTA, Phenoxyethanol
- PURPOSE
-
WARNINGS
Warnings: 1. Stop using if skin becomes red, swollen, itchy, etc during and after use. 2. Avoid using on irritated or sunburned skin by direct sunlight 3. Stop using on troubled skin part including eczema or dermatitis. 4. Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. 5. Keep away from the reach of baby and children. 6. Stored at room temperature only and keep away from direct sunlight.
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
EVERYDAY UV PROTECTOR SUN SCREEN
homosalate, octisalate, avobenzone, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71882-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 1.05 g in 15 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 0.67 g in 15 g Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone 0.45 g in 15 g Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 0.15 g in 15 g 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:71882-010-01 15 g in 1 POUCH; Type 0: Not a Combination Product 10/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2017 Labeler - Dermal Korea Co., Ltd (688990247) Registrant - Dermal Korea Co., Ltd (688990247) Establishment Name Address ID/FEI Business Operations Cosmecca Korea Co., Ltd. 688830827 manufacture(71882-010)