Label: NEUTROGENA MEN AGE FIGHTER MOISTURIZER SUNSCREEN SPF15- ensulizole and octinoxate cream

  • NDC Code(s): 10812-208-01
  • Packager: Johnson & Johnson Consumer 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 January 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Ensulizole 1%
    Octinoxate 6%

  • Purpose

    Sunscreen

  • Use

    • Helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Aging Alert

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    For external use only

    Do not use on damaged or broken skin

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

    Stop use and ask a doctor if rash occurs

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

  • Directions

    Apply liberally to face and neck after shaving or when skin needs moisture. You may experience mild tingling or redness. This is normal and temporary. If irritation persists, or is too strong, use once a day, every other day or until your skin adjusts. Then revert to daily use. For first use, puncture seal with end of cap.

    For Sunscreen Use:

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • Children under 6 months of age: Ask a doctor
  • Other information

    • Protect this product from excessive heat and direct sun
  • Inactive Ingredients

    Water, C12-15 Alkyl Benzoate , Cetyl Alcohol, Glycerin, Cetearyl Alcohol, Triethanolamine, Dimethicone, Phenoxyethanol, Panthenol, Retinol, Tocopheryl Acetate, Camellia Oleifera Leaf Extract , BHT , Tocopherol , Cetearyl Glucoside , Butylene Glycol , Polysorbate 20 , Carbomer , Disodium EDTA , Titanium Dioxide , Polyhydroxystearic Acid , Silica , Alumina , Methylparaben , Isopropylparaben , Isobutylparaben , Butylparaben

  • Questions?

    Call toll-free 866-638-4636 or 215-273-8755 (collect) or visit www.neutrogenamena.com.

  • SPL UNCLASSIFIED SECTION

    Dist. by Neutrogena Corp.
    Los Angeles, CA 90045

  • PRINCIPAL DISPLAY PANEL - 40g Tube Carton

    SEE NEW
    INFORMATION

    Neutrogena ®

    MEN

    Age
    Fighter
    FACE MOISTURIZER
    with
    sunscreen
    SPF15
    RETINOL
    MULTI-VITAMINS

    Clinically proven to
    reduce the look of lines,
    wrinkles, & sun damage
    Protects and hydrates

    Net wt 1.4 OZ [40g]

    PRINCIPAL DISPLAY PANEL - 40g Tube Carton
  • INGREDIENTS AND APPEARANCE
    NEUTROGENA MEN AGE FIGHTER MOISTURIZER   SUNSCREEN SPF15
    ensulizole and octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10812-208
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE10 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOPROPYLPARABEN (UNII: A6EOX47QK0)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    RETINOL (UNII: G2SH0XKK91)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10812-208-011 in 1 CARTON11/13/201212/01/2023
    140 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/13/201212/01/2023
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
    Registrant - Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. (830803164)
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