Label: ISA KNOX 365 SUN- zinc oxide, titanium dioxide, octinoxate cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 53208-502-01, 53208-502-02 - 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 10, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- WARNINGS AND PRECAUTIONS
- KEEP OUT OF REACH OF CHILDREN
- WHEN USING
- STOP USE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ISA KNOX 365 SUN
zinc oxide, titanium dioxide, octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53208-502 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 11.04 mL in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.2 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.03 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ZINC OXIDE (UNII: SOI2LOH54Z) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIMETHICONE (UNII: 92RU3N3Y1O) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) PANTHENOL (UNII: WV9CM0O67Z) METHYLPARABEN (UNII: A2I8C7HI9T) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) ETHYLPARABEN (UNII: 14255EXE39) SACCHARIDE ISOMERATE (UNII: W8K377W98I) ACETATE ION (UNII: 569DQM74SC) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) ZINC STEARATE (UNII: H92E6QA4FV) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) FRUIT (UNII: C2AIY4ERZC) MARITIME PINE (UNII: 50JZ5Z98QY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53208-502-02 1 in 1 BOX 1 NDC:53208-502-01 70 mL in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/30/2010 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