FDA.reportPublic FDA data

Neutrogena Clear Face Break Out Free

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2020-12-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:59:45

Label at a glance#

ProductNeutrogena Clear Face Break Out Free Sunscreen Broad Spectrum SPF55
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Label structure11 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

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.7%
Homosalate 4%
Octisalate 4.5%
Octocrylene 6%
Oxybenzone 4.5%

Purpose

OTC - PURPOSE SECTION

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 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

Visit www.neutrogena.com or call toll-free 800-299-4786 or 215-273-8755 (collect)

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®

clear face

BREAK-OUT FREE
liquid-lotion

SUNSCREEN
Broad Spectrum SPF 55
55

helioplex®
broad spectrum uva • uvb

won't cause break-outs
ultra-light, oil-free
water resistant (80 minutes)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

3.0 FL OZ (88mL)

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 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-000969968-0009-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
Oxybenzone95OOS7VE0YACTIB
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
LEVOMENOL24WE03BX2TIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CAPRYLOYL GLYCINE8TY5YO42NJIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CEDRUS ATLANTICA BARKITP1Q41UPFIACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
CHLORPHENESINI670DAL4SZIACT
CINNAMON BARK OILXE54U569ECIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
YEAST MANNAN91R887N59PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYESTER-70841698D2FIACT
PURSLANEM6S840WXG5IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SARCOSINEZ711V88R5FIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARETH-1004OH5W9UM87IACT
STEARETH-2V56DFE46J5IACT
TRIDECETH-63T5PCR2H0CIACT
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT

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
85a5a420-950e-499d-8a20-a0b886830e9e9bdd9507-d1ea-40d5-98f4-567d98e7a4b72020-12-23WarningsExact identifier
spl id: 85a5a420-950e-499d-8a20-a0b886830e9e
spl set id: 9bdd9507-d1ea-40d5-98f4-567d98e7a4b7

Reported adverse events (FAERS/openFDA)#

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