FDA.reportPublic FDA data

Avobenzone, Homosalate, Octisalate, and Octocrylene

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2023-11-21
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 21:20:02

Label at a glance#

ProductNeutrogena Beach Defense Water Plus Sun Protection Sunscreen Stick Broad Spectrum SPF 50 Plus
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
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 and evenly 15 minutes before sun exposure ensure complete coverage to the area above the lip, nose and tops of ears 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...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Avobenzone 3%Sunscreen
Homosalate 15%Sunscreen
Octisalate 5%Sunscreen
Octocrylene 10%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 and evenly 15 minutes before sun exposure
  • ensure complete coverage to the area above the lip, nose and tops of ears
  • 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
  • After use, twist stick down prior to capping to ensure complete closure.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Neopentyl Glycol Diethylhexanoate, Octyldodecyl Neopentanoate, Polyethylene, Isohexadecane, Butyloctyl Salicylate, Ozokerite, Paraffin, Synthetic Beeswax, C12-15 Alkyl Benzoate, VP/Eicosene Copolymer, Neopentyl Glycol Diisostearate, Dimethicone, Diethylhexyl 2,6-Naphthalate, Styrene/Acrylates Copolymer, Fragrance, BHT

Questions?

OTC - QUESTIONS SECTION

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 - 42 g Canister Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND

Beach

Defense ®

water + sun protection

sunscreen stick

BROAD SPECTRUM SPF 50+

50+

helioplex ®

broad spectrum uva•uvb

water resistant (80minutes)

NET WT. 1.5 OZ. (42 g)

Ntg_001Ntg_001

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-057469968-0574-2, 69968-0574-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
ISOHEXADECANE918X1OUF1EIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CERESINQ1LS2UJO3AIACT
PARAFFINI9O0E3H2ZEIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
NEOPENTYL GLYCOL DIISOSTEARATE4M6OQ34JWWIACT
DIMETHICONE92RU3N3Y1OIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
YELLOW WAX2ZA36H0S2VIACT
EICOSYL POVIDONEXQQ9MKE2BJIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
216220fe-1826-89ec-e063-6294a90a80562fb5d5d0-d511-4d44-9268-0bbe84392e9d2024-11-12WarningsExact identifier
spl set id: 2fb5d5d0-d511-4d44-9268-0bbe84392e9d

Reported adverse events (FAERS/openFDA)#

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