Label: NEUTROGENA SHEER ZINC FACE MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion

  • NDC Code(s): 69968-0623-2
  • 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 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc Oxide (21.6%)

  • Purpose

    Sunscreen

  • 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

    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 15 minutes before sun exposure
    • reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • 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
  • Other information

    • protect this product from excessive heat and direct sun
    • may stain some fabrics
  • Inactive ingredients

    Water, C12-15 Alkyl Benzoate, Styrene/Acrylates Copolymer, Octyldodecyl Citrate Crosspolymer, Phenyl Trimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Glycerin, Polyhydroxystearic Acid, Ethyl Methicone, Silica, Cetyl Dimethicone, Triethoxycaprylylsilane, Phenoxyethanol, Glyceryl Behenate, Sodium Chloride, Acrylates/Dimethicone Copolymer, Chlorphenesin, Phenethyl Alcohol, Avena Sativa (Oat) Kernel Flour, Caprylyl Glycol, Cetyl Dimethicone/Bis-Vinyldimethicone Crosspolymer, Tocopheryl Acetate, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice

  • Questions?

    Call toll-free 800-299-4786 or 215-273-8755 (collect). www.neutrogena.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON
    CONSUMER INC.
    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 59 mL Tube Carton

    Neutrogena ®

    DERMATOLOGIST RECOMMENDED BRAND

    Sheer Zinc

    Face

    mineral

    sunscreen

    BROAD SPECTRUM SPF 50

    50

    100% mineral active

    hypoallergenic

    oil free

    water resistant (80 minutes)

    2.0 FL OZ (59mL)

    Neutrogena-001

  • INGREDIENTS AND APPEARANCE
    NEUTROGENA SHEER ZINC FACE MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0623
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE216 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
    OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ETHYL METHICONE (8 MPA.S) (UNII: 3YWG8XYT8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    OATMEAL (UNII: 8PI54V663Y)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMER (UNII: AE7QA6TW0Q)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FEVERFEW (UNII: Z64FK7P217)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0623-21 in 1 CARTON01/31/2020
    159 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/31/2020
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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