Label: OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK- octinoxate, titanium dioxide, octisalate, ensulizole, bis-ethylhexyloxyphenol methoxyphenyl triazine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 53208-515-01, 53208-515-02 - 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 28, 2011
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- ACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK
octinoxate, titanium dioxide, octisalate, ensulizole, bis-ethylhexyloxyphenol methoxyphenyl triazine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53208-515 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.8 g in 100 g ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 3.9 g in 100 g DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE 0.5 g in 100 g HYDROXYPROLINE (UNII: RMB44WO89X) (HYDROXYPROLINE - UNII:RMB44WO89X) HYDROXYPROLINE 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) ALCOHOL (UNII: 3K9958V90M) ISODODECANE (UNII: A8289P68Y2) PANTHENOL (UNII: WV9CM0O67Z) METHYL METHACRYLATE (UNII: 196OC77688) INULIN (UNII: JOS53KRJ01) STEARIC ACID (UNII: 4ELV7Z65AP) TROMETHAMINE (UNII: 023C2WHX2V) CETYL PHOSPHATE (UNII: VT07D6X67O) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) XANTHAN GUM (UNII: TTV12P4NEE) ETHYLPARABEN (UNII: 14255EXE39) PROPYLPARABEN (UNII: Z8IX2SC1OH) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) EDETATE TRISODIUM (UNII: 420IP921MB) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53208-515-02 1 in 1 BOX 1 NDC:53208-515-01 40 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/06/2011 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
