FDA.reportPublic FDA data

Neutrogena HydroBoost Water Gel Sunscreen Broad Spectrum SPF 50

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2023-01-16
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:40:24

Label at a glance#

ProductNeutrogena HydroBoost Water Gel Sunscreen Broad Spectrum SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure10 sections

Indications and 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

Dosage and administration

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...

Storage and handling

protect this product from excessive heat and direct sun may stain some fabrics

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Avobenzone (2.7%)Sunscreen
Homosalate (9%)Sunscreen
Octisalate (5%)Sunscreen
Octocrylene (9%)Sunscreen
Oxybenzone (4.5%)Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin

OTC - WHEN USING SECTION

  • When using this product keep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun
  • may stain some fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label
PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-031569968-0315-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
PENTYLENE GLYCOL50C1307PZGIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SODIUM HYDROXIDE55X04QC32IIACT
CHLORPHENESINI670DAL4SZIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIDECETH-63T5PCR2H0CIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C VIOLET NO. 2350KA7O6HKIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ee85686d-2e15-24dc-e053-2a95a90a1013986126cb-f4e7-4cff-ba5d-a2e4e4c728472023-01-16WarningsExact identifier
spl id: ee85686d-2e15-24dc-e053-2a95a90a1013
spl set id: 986126cb-f4e7-4cff-ba5d-a2e4e4c72847

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.