Label: NEUTROGENA HEALTHY DEFENSE DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

  • NDC Code(s): 69968-0627-1, 69968-0627-2
  • 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 March 14, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone 3%Sunscreen
    Homosalate 12%Sunscreen
    Octisalate 5%Sunscreen
    Octocrylene 2.35%Sunscreen
    Oxybenzone 6%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

    For Sunscreen Use:

    • apply generously 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • 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
  • Inactive ingredients

    Water, Dimethicone, Diethylhexyl 2,6-Naphthalate, Glycerin, Trisiloxane, PEG-100 Stearate, Glyceryl Stearate, Cetearyl Alcohol, Behenyl Alcohol, Potassium Cetyl Phosphate, Caprylyl Methicone, Styrene/Acrylates Copolymer, Hydrogenated Palm Glycerides, Benzyl Alcohol, Ethylhexylglycerin, Methylparaben, Cetearyl Glucoside, Xanthan Gum, Propylparaben, Tocopherol, Disodium EDTA, Polymethyl Methacrylate, BHT, Methylisothiazolinone, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Pantothenic Acid

  • Questions?

    Call toll-free 866-638-4636 or 215-273-8755 (collect). www.neutrogena.com

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

    HEALTHY
    DEFENSE ®

    daily
    moisturizer
    with
    sunscreen

    Broad Spectrum
    SPF 50

    helioplex ®
    broad spectrum uva•uvb

    Lightweight, non-greasy moisturizer

    Neutrogena ®

    #1 DERMATOLOGIST RECOMMENDED
    FACIAL MOISTURE

    1.7 FL OZ (50mL)

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    NEUTROGENA HEALTHY DEFENSE DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 50 
    avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0627
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE120 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE23.5 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PANTOTHENIC ACID (UNII: 19F5HK2737)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0627-11 in 1 CARTON01/31/202008/02/2022
    114 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69968-0627-21 in 1 CARTON01/31/202007/20/2024
    250 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 finalpart35201/31/202007/20/2024
    Labeler - Johnson & Johnson Consumer Inc. (118772437)