Label: NEUTROGENA ULTRA SHEER BODY MIST SUNSCREEN BROAD SPECTRUM SPF 100 PLUS- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray

  • NDC Code(s): 69968-0300-5
  • 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 February 23, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone (3%), Homosalate (15%),
    Octisalate (5%), Octocrylene (10%),
    Oxybenzone (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
    • keep away from face to avoid breathing it

    • 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

    • Danger: Flammable. Contents under pressure. Do not use near fire, heat, or while smoking. Do not puncture or incinerate. Store at temperature below 120 °F (48°C). Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.
  • Directions

    • spray liberally and spread evenly by hand 15 minutes before sun exposure
    • hold container 4-6 inches from the skin to apply. Rub in
    • do not spray directly into face. Spray on hands and then apply to face. Rub in.
    • do not apply in windy conditions
    • use in a well-ventilated area
    • 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 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

    Alcohol Denat., Isobutane, Butyloctyl Salicylate, Acrylates/ Octylacrylamide Copolymer, Cyclopentasiloxane, Acrylates/Dimethicone Copolymer, Fragrance, Tocopheryl Acetate, Diethylhexyl 2,6 – Naphthalate, Ascorbyl Palmitate, Retinyl Palmitate, Tocopherol

  • 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 - 141 g Can Label

    Neutrogena ®
    #1 DERMATOLOGIST RECOMMENDED BRAND

    Ultra Sheer ®
    body mist

    sunscreen

    BROAD SPECTRUM SPF 100+
    100+
    helioplex ®
    broad spectrum uva•uvb

    weightless clean feel
    non-greasy
    water resistant (80 minutes)

    NET WT. 5.0 OZ. (141 g)

    Principal Display Panel - 141 g Can Label
  • INGREDIENTS AND APPEARANCE
    NEUTROGENA ULTRA SHEER BODY MIST  SUNSCREEN BROAD SPECTRUM SPF 100 PLUS
    avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    ISOBUTANE (UNII: BXR49TP611)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0300-5141 g in 1 CAN; Type 0: Not a Combination Product10/01/200905/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/200905/30/2024
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!