FDA.reportPublic FDA data

Avobenzone, Homosalate, Octisalate, and Octocrylene

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2023-01-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:39:19

Label at a glance#

ProductNeutrogena Rapid Tone Repair Retinol Plus Vitamin C 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

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, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Caprylyl Glycol, Fragrance, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Hydrolyzed Myrtus Communis Leaf Extract, Polysorbate 20, BHT, Retinol, Sodium Hyaluronate, Ascorbic Acid, Disodium EDTA, Sodium Hydroxide, Silica

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 29 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SAME PRODUCT
NEW LOOK!
Neutrogena ®
DERMATOLOGIST RECOMMENDED BRAND

Day
RAPID TONE REPAIR
RETINOL
+ VITAMIN C
MOISTURIZER
Sunscreen
Broad Spectrum SPF 30
protects skin & reduces the
look of dark spots for more
even skin tone
1 FL OZ (29mL)

PRINCIPAL DISPLAY PANEL - 29 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 29 mL Bottle Carton

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
69968-070569968-0705-1

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
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
STEARYL ALCOHOL2KR89I4H1YIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT
STEARETH-2153J3F32P58IACT
TRISILOXANE9G1ZW13R0GIACT
NYLON-12446U8J075BIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
XANTHAN GUMTTV12P4NEEIACT
POLYSORBATE 207T1F30V5YHIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
RETINOLG2SH0XKK91IACT
HYALURONATE SODIUMYSE9PPT4THIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM HYDROXIDE55X04QC32IIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
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
f306682d-ee5b-7340-e053-2995a90a75049c04387e-9a62-4ae4-9328-74ada2d3de182023-01-24WarningsExact identifier
spl id: f306682d-ee5b-7340-e053-2995a90a7504
spl set id: 9c04387e-9a62-4ae4-9328-74ada2d3de18

Reported adverse events (FAERS/openFDA)#

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