NDC | 70341-614-01, 70341-614-02 |
Set ID | 981fb31c-7d2a-4048-97a6-a6e81a412d36 |
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:
Water, Cyclopentasiloxane, Glycerin, Cyclohexasiloxane, Butylene Glycol Dicaprylate/Dicaprate, Phenyl Trimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Pentylene Glycol, Triethylhexanoin, Methyl Methacrylate Crosspolymer, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Hexyl Laurate, Sorbitan Sesquioleate, Disteardimonium Hectorite, Magnesium Sulfate, Phenoxyethanol, Iron Oxides (CI 77492), Tribehenin, Aluminum Hydroxide, Stearic Acid, Iron Oxides (CI 77491), Dimethicone, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Iron Oxides (CI 77499), Triethoxycaprylylsilane, Fragrance(Parfum), Ethylhexylglycerin, Dimethicone Crosspolymer, Disodium EDTA, Dimethicone/Vinyl Dimethicone Crosspolymer, Hydrogenated Castor Oil Isostearate, Ceramide NP, Propylene Glycol, Tocopheryl Acetate, Betula Platyphylla Japonica Juice, Rosa Centifolia Flower Water, Sodium PCA, Urea, Sea Water, Polyquaternium-51, Trehalose, Polyglutamic Acid, Sodium Hyaluronate, Triacetin, Caprylyl Glycol, Glyceryl Caprylate, 1,2-Hexanediol
- 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 MOIST BB 01 LIGHT BEIGE
titanium dioxide, octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70341-614 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 1.45 g in 15 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.75 g in 15 mL Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.44 g in 15 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70341-614-02 1 in 1 CARTON 05/01/2018 1 NDC:70341-614-01 15 mL in 1 TUBE; 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(70341-614)