FDA.reportPublic FDA data

Avobenzone, Homosalate, Octisalate, and Octocrylene

Manufacturer
Kenvue Brands LLC
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:42:43

Label at a glance#

ProductNeutrogena Ultra Sheer Moisturizing Face Serum Sunscreen Broad Spectrum SPF 60 Plus
Active ingredientOCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATE
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 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...

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 3%Sunscreen
Homosalate 13.5%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 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, Butyloctyl Salicylate, Glycerin, Alcohol Denat., Silica, Dimethicone, Aluminum Starch Octenylsuccinate, Polyurethane-62, Phenoxyethanol, Pentylene Glycol, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Acrylates/Dimethicone Copolymer, Glyceryl Stearate, Chlorphenesin, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Disodium EDTA, Trideceth-6, Sodium Hydroxide

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 50 mL Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

Neutrogena ®

DERMATOLOGIST

RECOMMENDED BRAND

Ultra Sheer ®

moisturizing

face serum

sunscreen

BROAD SPECTRUM

SPF 60+

FRAGRANCE FREE

60+

WITH VITAMIN E

soft + weightless

all-day hydration

oxybenzone free

water resistant (80 minutes)

1.7 FL OZ (50 mL)

Neutrogena_1Neutrogena_1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130086800103554GTIN-13: 0086800103554
EAN-13: 0086800103554
GTIN-12: 086800103554
UPC-A: 086800103554
GTIN storage (14 digits): 00086800103554		Neutrogena_1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0717-2Neutrogena Ultra Sheer Moisturizing Face Serum Sunscreen Broad Spectrum SPF 60 Plus1 in 1 CARTONLOTION18
69968-0717-2Neutrogena Ultra Sheer Moisturizing Face Serum Sunscreen Broad Spectrum SPF 60 Plus50 mL in 1 BOTTLE, PUMPLOTION508

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-071769968-0717-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYURETHANE-62TBK645J3J8IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
WATER059QF0KO0RIACT
OCTOCRYLENE5A68WGF6WMACTIB
TRIDECETH-63T5PCR2H0CIACT
SODIUM HYDROXIDE55X04QC32IIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ALCOHOL3K9958V90MIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PENTYLENE GLYCOL50C1307PZGIACT
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW)S7ZA3CCJ4MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
CHLORPHENESINI670DAL4SZIACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-07-15full-release2026-06-01 01:07:37

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 Ultra Sheer Moisturizing Face Serum Sunscreen Broad Spectrum SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCcdbe250b-2b64-78fd-e053-2995a90a6c332025-11-06WarningsExact identifier
ndc (package): 69968-0717-2
ndc (product): 69968-0717
ndc11 (package): 69968071702
spl id: 42231c65-abfc-d6ce-e063-6294a90a09aa
spl set id: cdbe250b-2b64-78fd-e053-2995a90a6c33

Reported adverse events (FAERS/openFDA)#

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