Label: THE HISTORY OF WHOO JIN HAE YOON SUN- octinoxate, titanium dioxide, amiloxate, bemotrizinol, diethylamino hydroxybenzoyl hexyl benzoate, ensulizole cream
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Contains inactivated NDC Code(s)
NDC Code(s): 53208-503-01, 53208-503-02 - 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 16, 2011
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INGREDIENTS AND APPEARANCE
THE HISTORY OF WHOO JIN HAE YOON SUN
octinoxate, titanium dioxide, amiloxate, bemotrizinol, diethylamino hydroxybenzoyl hexyl benzoate, ensulizole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53208-503 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL 1 mL in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.58 mL in 100 mL AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8) AMILOXATE 1.6 mL in 100 mL DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE 1 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TROMETHAMINE (UNII: 023C2WHX2V) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) CETYL PHOSPHATE (UNII: VT07D6X67O) FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS) PANTHENOL (UNII: WV9CM0O67Z) ALCOHOL (UNII: 3K9958V90M) METHYLPARABEN (UNII: A2I8C7HI9T) XANTHAN GUM (UNII: TTV12P4NEE) PROPYLPARABEN (UNII: Z8IX2SC1OH) ETHYLPARABEN (UNII: 14255EXE39) STEARIC ACID (UNII: 4ELV7Z65AP) EDETATE TRISODIUM (UNII: 420IP921MB) FRUIT (UNII: C2AIY4ERZC) TROLAMINE (UNII: 9O3K93S3TK) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) AQUILARIA MALACCENSIS STEM (UNII: 3S41TU3DPS) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53208-503-02 1 in 1 BOX 1 NDC:53208-503-01 60 mL in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/16/2011 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