FDA.reportPublic FDA data

Neutrogena Oil Free Moisture Broad Spectrum SPF15

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2023-01-24
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:39:07

Label at a glance#

ProductNeutrogena Oil Free Moisture Broad Spectrum SPF15
Active ingredientAVOBENZONE, 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

For sunscreen use: apply generously 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

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Avobenzone (1.5%)Sunscreen
Octisalate (5%)Sunscreen
Octocrylene (3%)Sunscreen
Oxybenzone (4%)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 generously 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, Octyldodecyl Neopentanoate, Glycerin, Emulsifying Wax NF, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Phenoxyethanol, Ethylhexylglycerin, Caprylyl Glycol, Carbomer, Triethanolamine, Methylparaben, Disodium EDTA, Ethylene Brassylate, Dipropylene Glycol, Dimethyl Heptenal

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Dist. by Neutrogena Corp.
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

oil-free
moisture

with
sunscreen

Broad Spectrum
SPF15

facial moisturizer
with sun protection

non-comedogenic
(doesn't clog pores)

Neutrogena ®

DERMATOLOGIST RECOMMENDED

4 FL. OZ. (118mL)

Principal Display Panel - 118 mL Bottle Carton
Principal Display Panel - 118 mL Bottle Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX1
OctisalateACTIVE INGREDIENT4X49Y0596W1
OctocryleneACTIVE INGREDIENT5A68WGF6WM1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
AvobenzoneACTIVE MOIETYG63QQF2NOX1
OctisalateACTIVE MOIETY4X49Y0596W1
OctocryleneACTIVE MOIETY5A68WGF6WM1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
2,6-Dimethyl-5-HeptenalINACTIVE INGREDIENTZ331YX9EL91
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438U1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
Dipropylene GlycolINACTIVE INGREDIENTE107L85C401
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K1
Ethylene BrassylateINACTIVE INGREDIENT9A87HC7ROD1
EthylhexylglycerinINACTIVE INGREDIENT147D247K3P1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE41
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T1
Octyldodecyl NeopentanoateINACTIVE INGREDIENTX8725R883T1
PEG-100 StearateINACTIVE INGREDIENTYD01N1999R1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
TrolamineINACTIVE INGREDIENT9O3K93S3TK1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10812-97910812-979-01, 10812-979-02, 10812-979-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TROLAMINE9O3K93S3TKIACT
METHYLPARABENA2I8C7HI9TIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLENE BRASSYLATE9A87HC7RODIACT
DIPROPYLENE GLYCOLE107L85C40IACT
2,6-DIMETHYL-5-HEPTENALZ331YX9EL9IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 286 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MethylparabenMETHYLPARABENA2I8C7HI9TTABLET / ORAL1.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KCAPSULE / ORAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKGEL / TRANSDERMAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION / RESPIRATORY (INHALATION)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION / OPHTHALMIC4 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, EMULSION / INTRAVENOUS59 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PERINEURAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii candidate
77 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TFILM / BUCCAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4CREAM / VAGINAL140 mgExact identifier — unii candidate
21 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TPOWDER, FOR SUSPENSION / ORAL75 mgExact identifier — unii candidate
79 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KLIQUID / INTRAVENOUS0.03 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSYSTEM / TOPICAL42 mgExact identifier — unii candidate
79 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / SUBCUTANEOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4SUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRADERMAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRA-ARTICULAR0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / PARENTERAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAMUSCULAR0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KGEL / VAGINAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
Dipropylene GlycolDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
3 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS15 mgExact identifier — unii candidate
79 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii candidate
79 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCAPSULE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAVENOUS0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUPPOSITORY / VAGINALNAExact identifier — unii candidate
79 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET / ORAL33.34 mgExact identifier — unii candidate
21 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KELIXIR / ORAL1.3 mg/5mlExact identifier — unii candidate
77 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET, FILM COATED / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / TOPICAL3.27 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates

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
f30a0103-2203-7b36-e053-2995a90ac6bf93534f5b-4a40-4356-9470-3bc0fd79b4982023-01-24WarningsExact identifier
spl id: f30a0103-2203-7b36-e053-2995a90ac6bf
spl set id: 93534f5b-4a40-4356-9470-3bc0fd79b498

Reported adverse events (FAERS/openFDA)#

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