FDA.reportPublic FDA data

Avobenzone, Homosalate, Octisalate, and Octocrylene

Manufacturer
Kenvue Brands LLC
Effective date
2025-11-05
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:16:31

Label at a glance#

ProductNeutrogena Rapid Wrinkle Repair Retinol Moisturizer Sunscreen Broad Spectrum SPF 30 Day
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
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 generously 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 ...

Storage and handling

You may experience mild redness, a warm, tingling sensation or flaking (skin exfoliation). These are normal, temporary indications that the formula is working. If effects persist/cause discomfort, reduce the frequency of use until your skin adjusts, then revert to daily use as tolerated. 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%), Homosalate (4%), Octisalate (4%), Octocrylene (2%)

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

SPL UNCLASSIFIED SECTION

For Sunscreen Use:

  • apply generously 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

  • You may experience mild redness, a warm, tingling sensation or flaking (skin exfoliation). These are normal, temporary indications that the formula is working. If effects persist/cause discomfort, reduce the frequency of use until your skin adjusts, then revert to daily use as tolerated.
  • protect this product from excessive heat and direct sun
  • may stain some fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, dimethicone, isononyl isononanoate, glycerin, cetyl alcohol, styrene/acrylates copolymer, steareth-21, trisiloxane, nylon-12, dimethicone/vinyl dimethicone crosspolymer, stearyl alcohol, PEG-100 stearate, glyceryl stearate, phenoxyethanol, caprylyl glycol, fragrance, chlorphenesin, xanthan gum, acrylates/C10-30 alkyl acrylate crosspolymer, hydrolyzed myrtus communis leaf extract, polysorbate 20, retinol, BHT, sodium hyaluronate, disodium EDTA, silica, ascorbic acid, sodium hydroxide

Questions?

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 - 29 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND

NOW WITH LESS

PACKAGING

SPF

30

RAPID WRINKLE REPAIR ®

RETINOL

MOISTURIZER

Sunscreen

Broad Spectrum SPF 30

protects skin & improves the

look of fine lines and wrinkles

1 FL OZ (29mL)

Neutrogena_01Neutrogena_01

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130070501021217GTIN-13: 0070501021217
EAN-13: 0070501021217
GTIN-12: 070501021217
UPC-A: 070501021217
GTIN storage (14 digits): 00070501021217		Neutrogena_1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0706-1Neutrogena Rapid Wrinkle Repair Retinol Moisturizer Sunscreen Broad Spectrum SPF 30 Day1 in 1 CARTONLOTION19
69968-0706-1Neutrogena Rapid Wrinkle Repair Retinol Moisturizer Sunscreen Broad Spectrum SPF 30 Day29 mL in 1 BOTTLE, PUMPLOTION299

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-070669968-0706-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT
STEARETH-2153J3F32P58IACT
TRISILOXANE9G1ZW13R0GIACT
NYLON-12446U8J075BIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
STEARYL ALCOHOL2KR89I4H1YIACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
XANTHAN GUMTTV12P4NEEIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
POLYSORBATE 207T1F30V5YHIACT
RETINOLG2SH0XKK91IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
HYALURONATE SODIUMYSE9PPT4THIACT
EDETATE DISODIUM7FLD91C86KIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
Neutrogena Rapid Wrinkle Repair Retinol Moisturizer Sunscreen Broad Spectrum SPF 30 DayAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCd3ebe2a9-434e-497c-8fed-b5c73c70a58b2025-11-05WarningsExact identifier
ndc (package): 69968-0706-1
ndc (product): 69968-0706
ndc11 (package): 69968070601
spl id: 42262596-67bd-dea5-e063-6294a90a7ec9
spl set id: d3ebe2a9-434e-497c-8fed-b5c73c70a58b

Reported adverse events (FAERS/openFDA)#

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