FDA.reportPublic FDA data

Sunscreen

Manufacturer
RETAIL BUSINESS SERVICES , LLC | Consumer Product Partners, LLC
Effective date
2025-02-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:40:58

Label at a glance#

ProductSunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure13 sections

Indications and uses

helps prevent sunburn if used as directed with other skin 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 apply to all skin exposed to the sun 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 prot...

Label contents#

Full prescribing information#

active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other skin 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

Do not use

OTC - DO NOT USE SECTION

  • On damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • Keep out of eyes.  Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • 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

SPL UNCLASSIFIED SECTION

  • protect the product in the container from excessive heat and direct sun

inactive ingredients

INACTIVE INGREDIENT SECTION

water, styrene/acrylates copolymer, silica, diethylhexyl 2,6-naphthalate, beeswax, glyceryl stearate, PEG-100 stearate, glycerin, caprylyl methicone, cetyl dimethicone, sodium polyacrylate, acrylates/C12-22 alkyl methacrylate copolymer, dimethicone, xanthan gum, pentylene glycol, trimethylsiloxysilicate, disodium EDTA, fragrance, BHT, benzyl alcohol, chlorphenesin

ADVERSE REACTION

ADVERSE REACTIONS SECTION

This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributer of Neutrogena Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 70.

MAY STAIN OR DAMAGE SOME FABRICS OR SURFACES.

Distributed by: ADUSA Distribution, LLC

Salisbury, NC 28147

1-833-922-3872

Quality Guaranteed or your money back.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAREONE

Compare to Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 70*

Sheer Touch Sunscreen Lotion

SPF 70 UVA/UVB Protection

  • Water resistant (80 mins)
  • Clean & lightweight feel
  • Quickly absorbs
  • Formulated without Oxybenzone & Octinoxate

NET 3 FL OZ (88 mL)

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-978SUNSCREEN (AVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENE) SPRAY [RETAIL BUSINESS SERVICES , LLC]4Legacy NDC20250228_0cb6b641-b055-4b08-8dfd-0fa227468064.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72476-97872476-978-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
STYRENE44LJ2U959VIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
YELLOW WAX2ZA36H0S2VIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERINPDC6A3C0OXIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CETYL DIMETHICONE 1505L694Y0T22IACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER7K68DGG29PIACT
DIMETHICONE92RU3N3Y1OIACT
XANTHAN GUMTTV12P4NEEIACT
PENTYLENE GLYCOL50C1307PZGIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
BENZYL ALCOHOLLKG8494WBHIACT
CHLORPHENESINI670DAL4SZIACT
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
3ff65ca1-81ed-e1e4-e063-6394a90a0ed70cb6b641-b055-4b08-8dfd-0fa2274680642025-09-29Warnings, Adverse reactionsExact identifier
spl set id: 0cb6b641-b055-4b08-8dfd-0fa227468064

Reported adverse events (FAERS/openFDA)#

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