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

  • NDC Code(s): 69968-0677-1
  • 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 9, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    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
    • package contains small parts, which could cause a choking hazard
  • Inactive ingredients

    Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Synthetic Wax, Paraffin, Silica, Neopentyl Glycol Diethylhexanoate, Ozokerite, Isopropyl Myristate, Adipic Acid/Diglycol Crosspolymer, Triethoxycaprylylsilane, Neopentyl Glycol Diisostearate, Caprylyl Glycol, Avena Sativa (Oat) Kernel Oil

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 13 g Stick Label

    Neutrogena ®

    DERMATOLOGIST RECOMMENDED BRAND

    Pure & Free ®

    baby

    zinc oxide

    sunscreen stick

    BROAD SPECTRUM

    SPF 50

    50

    pureSCREEN ®

    broad spectrum uva.uvb

    100% zinc oxide

    active
    fragrance free
    ideal for
    delicate skin
    ideal for face
    and body
    water resistant
    (80 minutes)

    NET WT

    0.47 OZ (13g)

    Ntg001

  • INGREDIENTS AND APPEARANCE
    NEUTROGENA PURE AND FREE SUNSCREEN BROAD SPECTRUM SPF 50 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0677
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE216 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
    CERESIN (UNII: Q1LS2UJO3A)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0677-11 in 1 BLISTER PACK10/05/2020
    113 g in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/05/2020
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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