Label: SOORYEHAN DABITYOON JIYOON TWO WAY CAKE 23- titanium dioxide, octinoxate powder
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Contains inactivated NDC Code(s)
NDC Code(s): 53208-418-01, 53208-418-02 - Packager: LG Household and Healthcare, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 30, 2010
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- ACTIVE INGREDIENT
- WARNINGS AND PRECAUTIONS
- KEEP OUT OF REACH OF CHILDREN
- WHEN USING
- STOP USE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SOORYEHAN DABITYOON JIYOON TWO WAY CAKE 23
titanium dioxide, octinoxate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53208-418 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.5 g in 100 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 14.00 g in 100 g Inactive Ingredients Ingredient Name Strength Talc (UNII: 7SEV7J4R1U) Barium Sulfate (UNII: 25BB7EKE2E) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Methylparaben (UNII: A2I8C7HI9T) Kaolin (UNII: 24H4NWX5CO) PROPYLPARABEN (UNII: Z8IX2SC1OH) PERSIC OIL (UNII: 5M26W7T072) AMERICAN GINSENG (UNII: 8W75VCV53Q) CAROB (UNII: 5MG5Z946UO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53208-418-02 1 in 1 BOX 1 NDC:53208-418-01 14 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/30/2010 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