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

  • NDC Code(s): 10356-323-04, 10356-323-11, 10356-323-25, 10356-323-27
  • Packager: Beiersdorf Inc
  • 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 December 30, 2022

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  • ACTIVE INGREDIENT

    Active ingredients
    Ensulizole 2%
    Octinoxate 7.5%
    Octisalate 4.5%
    Titanium Dioxide 2.4%
    Zinc Oxide 4.8%

  • PURPOSE

    Purpose
    Sunscreens

  • INDICATIONS & USAGE

    Uses
    • helps prevent sunburn • if used as directed with other sun protection
    measures (see Directions), decreases the risk of skin cancer and early skin aging
    caused by the sun.

  • WARNINGS

    Warnings
    For external use only

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

    When using this product keep out of eyes.
    Rinse with water to remove

  • STOP USE

    Stop use and ask a doctor if irritation occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed,
    get medical help or contact a Poison Control
    Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    For sunscreen use: • apply liberally 15
    minutes before sun exposure • use a water
    resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • Sun Protection Measures. Spending time in
    the sun increases your risk of skin cancer and
    early skin aging. To decrease this risk regularly
    use a sunscreen with a Broad Spectrum SPF
    value of 15 or higher and other sun protection
    measures including:
    • limit time in the sun, especially from
    10 a.m.-2 p.m.• wear long-sleeved shirts,
    pants, hats, and sunglasses.
    • Children under 6 months of age: Ask a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Glycerin, C12-15 Alkyl Benzoate,

    Dimethicone, Cyclomethicone, Methylpropanediol,

    Cetearyl Alcohol, Cetyl Alcohol, Ceteareth-20,

    Phenoxyethanol, Glyceryl Stearate SE, Sodium

    Lactate, Lactic Acid, 1,2-Hexanediol,

    Hydrogenated Coco-Glycerides,

    VP/Hexadecene Copolymer, Xanthan Gum,

    PEG-40 Castor Oil, Sodium Hydroxide,

    Trisodium EDTA, Alumina, Sodium Cetearyl

    Sulfate, Triethoxycaprylylsilane, Simethicone

  • QUESTIONS

    Questions or comments

    1-800-227-4703

  • PRINCIPAL DISPLAY PANEL

    Eucerin

    Daily Protection

    Face Lotion and Sunscreen

    Broad Spectrum SPF 30

    Moisturizes and helps protect skin against dailu UV exposure

    Fragrance free Non-comedogenic

    Dermatological skincare

    eucdailyprotectionfop

    eucdailyprotectionbop

  • INGREDIENTS AND APPEARANCE
    EUCERIN DAILY PROTECTION FACE 
    ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10356-323
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.4 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALKYL (C12-15) 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)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10356-323-0430 mL in 1 TUBE; Type 0: Not a Combination Product08/12/2015
    2NDC:10356-323-255 mL in 1 TUBE; Type 0: Not a Combination Product08/12/2015
    3NDC:10356-323-274 mL in 1 PACKET; Type 0: Not a Combination Product08/12/2019
    4NDC:10356-323-11118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/12/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/12/2015
    Labeler - Beiersdorf Inc (001177906)
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