NDC | 70341-618-01, 70341-618-02 |
Set ID | 18462a1f-a8de-4df5-8832-799cfe463a8c |
Category | HUMAN OTC DRUG LABEL |
Packager | The Saem International Co., Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
-
INACTIVE INGREDIENT
Inactive ingredients:
Nelumbo Nucifera Flower Water, Cyclopentasiloxane, Glycerin, Diphenylsiloxy Phenyl Trimethicone, Trimethylsiloxysilicate, PEG-8 Dimethicone, Butylene Glycol, Niacinamide, Butylene Glycol Dicaprylate/Dicaprate, Pentylene Glycol, Methyl Methacrylate Crosspolymer, PEG-10 Dimethicone, Iron Oxides (CI 77492), Mica (CI 77019), Diphenyl Dimethicone, Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Magnesium Sulfate, Stearic Acid, Alumina, Disteardimonium Hectorite, Iron Oxides (CI 77491), Fragrance(Parfum), Triethoxycaprylylsilane, Aluminum Hydroxide, Iron Oxides (CI 77499), Ethylhexylglycerin, Adenosine, Disodium EDTA, Dimethicone, Water, Dimethicone Crosspolymer, Hydrogenated Castor Oil Isostearate, Polyglutamic Acid
- PURPOSE
-
WARNINGS
Warnings:
For external use only
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.
4. Keep out of reach of babies and children.
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SAEMMUL AQUA GLOW CUSHION 02 NATURAL BEIGE
titanium dioxide, octinoxate, octisalate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70341-618 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 1.33 g in 15 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.00 g in 15 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 0.60 g in 15 g Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70341-618-02 1 in 1 CARTON 05/01/2018 1 NDC:70341-618-01 15 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 05/01/2018 Labeler - The Saem International Co., Ltd. (689402402) Registrant - The Saem International Co., Ltd. (689402402) Establishment Name Address ID/FEI Business Operations Cosmax, Inc. 689049693 manufacture(70341-618)