Label: EUCERIN- octinoxate, zinc oxide, octisalate, ensulizole, titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-5967-0 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 10356-322
- Category: HUMAN OTC DRUG LABEL
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 May 22, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Water, Glycerin, C12-15
Alkyl Benzoate, Dimethicone, Cyclomethicone,
Cetyl Alcohol, Cetearyl Alcohol, Ceteareth-
20, Glyceryl Stearate SE, Sodium Lactate,
Lactic Acid, Hydrogenated Coco-
Glycerides, VP/Hexadecene Copolymer,
PEG-40 Castor Oil, Sodium Cetearyl Sulfate,
Xanthan Gum, Trisodium EDTA, Sodium
Hydroxide, Alumina, Simethicone,
Phenoxyethanol, DMDM Hydantoin
- INDICATIONS & USAGE
- ACTIVE INGREDIENT
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- QUESTIONS
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EUCERIN
octinoxate, zinc oxide, octisalate, ensulizole, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-5967(NDC:10356-322) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 7.5 mL in 100 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 4.85 mL in 100 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 4.5 mL in 100 mL Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole 2 mL in 100 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 2.38 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) CETYL ALCOHOL (UNII: 936JST6JCN) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SODIUM LACTATE (UNII: TU7HW0W0QT) LACTIC ACID (UNII: 33X04XA5AT) COCO-GLYCERIDES (UNII: ISE9I7DNUG) POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF) SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE TRISODIUM (UNII: 420IP921MB) SODIUM HYDROXIDE (UNII: 55X04QC32I) ALUMINUM OXIDE (UNII: LMI26O6933) PHENOXYETHANOL (UNII: HIE492ZZ3T) DMDM HYDANTOIN (UNII: BYR0546TOW) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-5967-0 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/19/2008 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel
