Label: NEUTROGENA PURE AND FREE BABY SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 11, 2024

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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 value of SPF 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, Caprylyl Glycol, Cetyl Dimethicone/Bis-Vinyldimethicone Crosspolymer, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice

  • Questions or comments?

    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 - 88 mL Tube Label

    Neutrogena ®

    pure & free ®

    baby

    SUNSCREEN

    Broad Spectrum SPF 50

    50

    purescreen ®

    100% zinc oxide uva.uvb

    ACCEPTED

    e

    NATIONALECZEMA.ORG

    NATIONAL

    ECZEMA

    ASSOCIATION

    TEAR FREE

    fragrance free

    water resistant

    (80 minutes)

    #1 DERMATOLOGIST

    RECOMMENDED SUNCARE

    3.0 FL OZ (88mL)

    Ntg_001

  • INGREDIENTS AND APPEARANCE
    NEUTROGENA PURE AND FREE BABY  SUNSCREEN BROAD SPECTRUM SPF 50
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0275
    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)  
    ETHYL METHICONE (8 MPA.S) (UNII: 3YWG8XYT8H)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMER (UNII: AE7QA6TW0Q)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    FEVERFEW (UNII: Z64FK7P217)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0275-388 mL in 1 TUBE; Type 0: Not a Combination Product10/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/01/2016
    Labeler - Kenvue Brands LLC (118772437)
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