Label: EUCERIN- octinoxate, zinc oxide, octisalate, ensulizole, titanium dioxide lotion

  • 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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  • DOSAGE & ADMINISTRATION

    Enter section text here

  • 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

    Use a gentle cleanser such as Eucerin Gentle Hydrating Cleanser.
    After cleansing apply to face and neck every morning

  • ACTIVE INGREDIENT

    Octinoxate, Zinc Oxide,Octisalate, Ensulizole, Titanium Dioxide

  • STOP USE

    Stop use and consult a doctor if irritation develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • QUESTIONS

    Questions Comments 1-800-227-4703

  • WARNINGS

    For external use only. Keep out of eyes

  • PRINCIPAL DISPLAY PANEL

    image of package label

    NDC 54868-5967-0

    Eucerin

    Dermatologist Recommended

    Sensitive Skin

    Everyday Protection Face Lotion

    UVA + UVB SPF 30 Protection

    Non-Comedogenic · Fragrance-Free

    DERMATOLOGICAL SKINCARE

    4 FL.OZ. 118mL




  • INGREDIENTS AND APPEARANCE
    EUCERIN 
    octinoxate, zinc oxide, octisalate, ensulizole, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5967(NDC:10356-322)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 mL  in 100 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide4.85 mL  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate4.5 mL  in 100 mL
    Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole2 mL  in 100 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide2.38 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-5967-0118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/19/2008
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel