NDC | 70341-619-01, 70341-619-02 |
Set ID | 147f5ea2-f519-4d42-83c8-73e34d5585d5 |
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, Talc, Glycerin, Methylpropanediol, Cyclomethicone, PEG-10 Dimethicone, Hexyldecyl Myristoyl Methylaminopropionate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Isopropyl Isostearate, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Betaine, Triethylhexanoin, Magnesium Sulfate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Glycosyl Trehalose, Iron Oxides(CI 77492), Phenoxyethanol, Acrylates/Dimethicone Copolymer, Hydrogenated Starch Hydrolysate, Methicone, Iron Oxides(CI 77491), Iron Oxides(CI 77499), Palmitic Acid, Ethylhexylglycerin, Portulaca Oleracea Extract, Tocopheryl Acetate, Fragrance, Aluminum Hydroxide, Aluminum Stearate, Dimethicone, Butylene Glycol, Madecassoside, Aloe Barbadensis Leaf Water, Prunus Armeniaca (Apricot) Kernel Oil, Rosa Centifolia Flower Water, Tilia Vulgaris Flower Extract, Betula Alba Juice, Aloe Barbadensis Leaf Extract, Althaea Rosea Flower Extract, Benzyl Alcohol, Dehydroacetic Acid, Disodium EDTA
- 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 A CLEAN BB
titanium dioxide, octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70341-619 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 1.18 g in 15 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.45 g in 15 mL Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.28 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:70341-619-02 1 in 1 CARTON 05/01/2018 1 NDC:70341-619-01 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 Kolmar Korea Co., Ltd. 689512611 manufacture(70341-619)