Neutrogena hydro boost water gel lotion sunscreen spf 50

• NDC Code(s): 69968-0315-3
• 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 September 5, 2022

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

• Download DRUG LABEL INFO: PDF XML
• Official Label (Printer Friendly)

• SPL UNCLASSIFIED SECTION
• ACTIVE INGREDIENT

  Active Ingredients	Purpose
  Avobenzone (2.7%)	Sunscreen
  Homosalate (9%)	Sunscreen
  Octisalate (5%)	Sunscreen
  Octocrylene (9%)	Sunscreen
  Oxybenzone (4.5%)	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, Glycerin, Alcohol Denat., Caprylyl Methicone, Diisopropyl Adipate, Silica, Dicaprylyl Carbonate, Dimethicone, Polyurethane-62, Phenoxyethanol, Hydroxyacetophenone, Pentylene Glycol, Aluminum Starch Octenylsuccinate, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Acrylates/Dimethicone Copolymer, Glyceryl Stearate, Fragrance, Chlorphenesin, Menthyl Lactate, Tocopheryl Acetate, Disodium EDTA, Trideceth-6, Hydrolyzed Hyaluronic Acid, Sodium Hydroxide, Violet 2,Blue 1

• Questions or comments?

  Call toll-free 800-299-4786 or 215-273-875 (collect) www.neutrogena.com

• SPL UNCLASSIFIED SECTION

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

• PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

  Neutrogena ®

  #1 DERMATOLOGIST RECOMMENDED BRAND

  Hydro
  Boost
  water gel lotion

  sunscreen

  BROAD SPECTRUM SPF 50

  50

  helioplex ®

  broad spectrum uva.uvb

  invisible finish
  non-greasy

  water resistant(80 minutes)

  3.0 fl. oz. (88 mL)

  

• INGREDIENTS AND APPEARANCE

  NEUTROGENA HYDROBOOST WATER GEL SUNSCREEN BROAD SPECTRUM SPF 50  avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

  Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0315 Route of Administration TOPICAL

  Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 27 mg  in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg  in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg  in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 90 mg  in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 45 mg  in 1 mL

  Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)   ALCOHOL (UNII: 3K9958V90M)   GLYCERIN (UNII: PDC6A3C0OX)   CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)   DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)   DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)   DIMETHICONE (UNII: 92RU3N3Y1O)   PHENOXYETHANOL (UNII: HIE492ZZ3T)   HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)   PENTYLENE GLYCOL (UNII: 50C1307PZG)   ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)   GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)   SODIUM HYDROXIDE (UNII: 55X04QC32I)   CHLORPHENESIN (UNII: I670DAL4SZ)   MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)   .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)   TRIDECETH-6 (UNII: 3T5PCR2H0C)   EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)   SILICON DIOXIDE (UNII: ETJ7Z6XBU4)   D&C VIOLET NO. 2 (UNII: 350KA7O6HK)   FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0315-3 88 mL in 1 TUBE; Type 0: Not a Combination Product 10/01/2017

  Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2017

  Labeler - Johnson & Johnson Consumer Inc. (002347102)