FDA.reportPublic FDA data

Neutrogena Clear Face Breakout Free Oil Free Broad Spectrum SPF 55

Manufacturer
Kenvue Brands LLC
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:42:34

Label at a glance#

ProductNeutrogena Clear Face Breakout Free Oil Free Broad Spectrum SPF 55
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 generously 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 SPF value of 15 or higher and other sun protection measures including: limit time in th...

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 4%Sunscreen
Octisalate 4.5%Sunscreen
Octocrylene 6%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

SPL UNCLASSIFIED 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 generously 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 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

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Silica, Cetyl Dimethicone, Styrene/Acrylates Copolymer, C12-15 Alkyl Benzoate, Steareth-100, Ethylhexylglycerin, Phenoxyethanol, Caprylyl Glycol, Sodium Polyacrylate, Dimethicone, Steareth-2, Polyester-7, Chlorphenesin, Propylene Glycol, Ethylhexyl Stearate, Neopentyl Glycol Diheptanoate, Bisabolol, Disodium EDTA, Butylene Glycol, Acrylates/Dimethicone Copolymer, Diethylhexyl 2,6-Naphthalate, Mannan, Xanthan Gum, BHT, Capryloyl Glycine, Trideceth-6, Sarcosine, Cedrus Atlantica Bark Extract, Cinnamomum Zeylanicum Bark Extract, Portulaca Oleracea Extract

Questions?

OTC - QUESTIONS SECTION

Call toll-free 800-582-4048 or 215-273-8755 (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

Clear Face
BREAKOUT FREE
oil-free
sunscreen
BROAD SPECTRUM SPF 55

55

helioplex ®
broad spectrum uva•uvb

won't cause breakouts
ultra-light

water resistant (80 minutes)

3.0 FL OZ (88 mL)

Principal Display Panel - 88 mL Tube Label
Principal Display Panel - 88 mL Tube Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0573-3Neutrogena Clear Face Breakout Free Oil Free Broad Spectrum SPF 5588 mL in 1 TUBELOTION889

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-057369968-0573-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
STEARETH-1004OH5W9UM87IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DIMETHICONE92RU3N3Y1OIACT
STEARETH-2V56DFE46J5IACT
POLYESTER-70841698D2FIACT
CHLORPHENESINI670DAL4SZIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
LEVOMENOL24WE03BX2TIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
YEAST MANNAN91R887N59PIACT
XANTHAN GUMTTV12P4NEEIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CAPRYLOYL GLYCINE8TY5YO42NJIACT
TRIDECETH-63T5PCR2H0CIACT
SARCOSINEZ711V88R5FIACT
CEDRUS ATLANTICA BARKITP1Q41UPFIACT
CINNAMON BARK OILXE54U569ECIACT
PURSLANEM6S840WXG5IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82024-11-12full-release2026-06-01 00:37:07

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
Neutrogena Clear Face Breakout Free Oil Free Broad Spectrum SPF 55AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLC3e25a4ce-dbdd-4830-a3d8-a2dfb3bcb0782025-11-06WarningsExact identifier
ndc (package): 69968-0573-3
ndc (product): 69968-0573
ndc11 (package): 69968057303
spl id: 422639ae-af95-58fc-e063-6294a90aecf6
spl set id: 3e25a4ce-dbdd-4830-a3d8-a2dfb3bcb078

Reported adverse events (FAERS/openFDA)#

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