FDA.reportPublic FDA data

Neutrogena Oil-Free Moisture

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2023-04-13
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:33:01

Label at a glance#

ProductNeutrogena Oil-Free Moisture Sunscreen Broad Spectrum SPF 35
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

For Sunscreen Use: apply liberally and evenly 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating 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: lim...

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 3%, Homosalate 12%, Octisalate 5%, Octocrylene 2.35%, Oxybenzone 6%

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

For Sunscreen Use:

  • apply liberally and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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, Dimethicone, Diethylhexyl 2,6-Naphthalate, Glycerin, Trisiloxane, PEG-100 Stearate, Glyceryl Stearate, Cetearyl Alcohol, Behenyl Alcohol, Caprylyl Methicone, Potassium Cetyl Phosphate, Styrene/Acrylates Copolymer, Hydrogenated Palm Glycerides, Benzyl Alcohol, Ethylhexylglycerin, Methylparaben, Cetearyl Glucoside, Xanthan Gum, Propylparaben, Disodium EDTA, BHT, Methylisothiazolinone

Questions or comments?

OTC - QUESTIONS SECTION

Visit www.neutrogena.com or call toll-free 800-582-4048 or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 73 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

oil-free
moisture

with
sunscreen

BROAD SPECTRUM
SPF 35

facial moisturizer
with UVA/UVB protection

non-comedogenic
(won't clog pores)
Neutrogena ®

DERMATOLOGIST RECOMMENDED

2.5 FL OZ (73mL)

PRINCIPAL DISPLAY PANEL - 73 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 73 mL Bottle Carton

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-034269968-0342-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
TRISILOXANE9G1ZW13R0GIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DOCOSANOL9G1OE216XYIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
BENZYL ALCOHOLLKG8494WBHIACT
METHYLPARABENA2I8C7HI9TIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
XANTHAN GUMTTV12P4NEEIACT
PROPYLPARABENZ8IX2SC1OHIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
HYDROGENATED PALM GLYCERIDESYCZ8EM144QIACT
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
f93125a9-354a-31d9-e053-6394a90a213fc602e1b3-1113-4097-810d-fd07a1e608bf2023-04-13WarningsExact identifier
spl id: f93125a9-354a-31d9-e053-6394a90a213f
spl set id: c602e1b3-1113-4097-810d-fd07a1e608bf

Reported adverse events (FAERS/openFDA)#

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