NDC | 53208-513-01, 53208-513-02 |
Set ID | 258c99fb-5daf-4f58-ae48-12fc5b6c0bc3 |
Category | HUMAN OTC DRUG LABEL |
Packager | LG Household and Healthcare, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- WARNINGS AND PRECAUTIONS
- KEEP OUT OF REACH OF CHILDREN
- WHEN USING
- STOP USE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
WHOO GONG JIN HYANG JIN HAE YOON SUN
bisoctrizole, octinoxate, zinc oxide, titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53208-513 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.2 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4.8 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.125 g in 100 g BISOCTRIZOLE (UNII: 8NT850T0YS) (BISOCTRIZOLE - UNII:8NT850T0YS) BISOCTRIZOLE 2.125 g in 100 g Inactive Ingredients Ingredient Name Strength TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIMETHICONE (UNII: 92RU3N3Y1O) MICA (UNII: V8A1AW0880) METHYLPARABEN (UNII: A2I8C7HI9T) LAUROYL LYSINE (UNII: 113171Q70B) PROPYLPARABEN (UNII: Z8IX2SC1OH) STEARIC ACID (UNII: 4ELV7Z65AP) GOLD (UNII: 79Y1949PYO) BORON NITRIDE (UNII: 2U4T60A6YD) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) MAGNESIUM MYRISTATE (UNII: Z1917F0578) MAGNESIUM (UNII: I38ZP9992A) Ceramide 3 (UNII: 4370DF050B) POLYSORBATE 60 (UNII: CAL22UVI4M) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) SORBITAN (UNII: 6O92ICV9RU) DIOSCOREA JAPONICA ROOT (UNII: I43FCF3356) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53208-513-02 1 in 1 BOX 1 NDC:53208-513-01 18 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/23/2011 Labeler - LG Household and Healthcare, Inc. (688276187) Registrant - LG Household and Healthcare, Inc. (688276187) Establishment Name Address ID/FEI Business Operations LG Household and Healthcare, Inc. 688276187 manufacture