Label: NEUTROGENA SPORT ACTIVE DEFENSE SPF 70- avobenzone, homosalate, octisalate, octocrylene spray

  • NDC Code(s): 69968-0823-5
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 15, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone (3%),Sunscreen
    Homosalate (15%),Sunscreen
    Octisalate (5%),Sunscreen
    Octocrylene (10%)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 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

    Warning: 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 the 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 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

    Alcohol Denat., Isobutane, Butyloctyl Salicylate, Dicaprylyl Carbonate, Diethylhexyl 2,6-Naphthalate, Polyester-7, Acrylates/Octylacryl-amide Copolymer, Neopentyl Glycol Diheptanoate, Fragrance, Tocopheryl Acetate, Ascorbyl Palmitate

  • 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 - 141 g Can Label

    NEW

    Neutrogena®

    DERMATOLOGIST RECOMMENDED BRAND

    Sport

    active defense

    sunscreen

    70

    BROAD SPECTRUM SPF 70

    skin barrier protection

    helioplex®

    broad spectrum uva●uvb

    ANTIOXIDANTS

    VITAMINS C & E

    SWEAT + SUN + H2O DEFENSE

    protects & refreshes

    non-sticky ● quick-drying

    water resistant (80 minutes)

    NET WT 5.0 OZ (141 g)

    Neutrogena_01

  • INGREDIENTS AND APPEARANCE
    NEUTROGENA SPORT ACTIVE DEFENSE SPF 70 
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0823
    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
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ISOBUTANE (UNII: BXR49TP611)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    POLYESTER-7 (UNII: 0841698D2F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0823-5141 g in 1 CAN; Type 0: Not a Combination Product12/04/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02012/04/2023
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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