FDA.reportPublic FDA data

Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF45

Manufacturer
A-S Medication Solutions
Effective date
2024-01-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:07:35

Label at a glance#

ProductNeutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF45
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

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 10%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, Styrene/Acrylates Copolymer, Silica, Dimethicone, Potassium Cetyl Phosphate, Benzyl Alcohol, Beeswax, Caprylyl Methicone, Glyceryl Stearate, PEG-100 Stearate, Cetyl Dimethicone, Caprylyl Glycol, Ethylhexylglycerin, Aluminum Starch Octenylsuccinate, Behenyl Alcohol, Acrylates/Dimethicone Copolymer, Xanthan Gum, Sodium Polyacrylate, Chlorphenesin, Dimethicone PEG - 10/15 Crosspolymer, Hydrolyzed Jojoba Esters, Fragrance, Disodium EDTA, Ethylhexyl Stearate, Tocopheryl Acetate, BHT, Trideceth-6, Jojoba Esters

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-6558

NDC: 50090-6558-0 88 mL in a TUBE / 12 in a CARTON

avobenzone, homosalate, octisalate, and octocrylene lotion

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6558-0Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF4512 in 1 CARTONLOTION125
50090-6558-0Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF4588 mL in 1 TUBELOTION885

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6558NEUTROGENA ULTRA SHEER DRY TOUCH SUNSCREEN BROAD SPECTRUM SPF45 (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [A-S MEDICATION SOLUTIONS]5Current NDC, 2 package rows20240119_bfb1fdbe-883f-4d1d-9131-a46da9827788.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6558-0ML - Milliliter50090-655840347b11-253e-4258-9bea-01f9df5b771c12024-02-14

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-655850090-6558-0
69968-0553

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIMETHICONE92RU3N3Y1OIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
BENZYL ALCOHOLLKG8494WBHIACT
YELLOW WAX2ZA36H0S2VIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
DOCOSANOL9G1OE216XYIACT
XANTHAN GUMTTV12P4NEEIACT
CHLORPHENESINI670DAL4SZIACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
TRIDECETH-63T5PCR2H0CIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
WATER059QF0KO0RIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC2510d9fe-2aa7-44ee-9525-ad5163dfee942025-11-06WarningsExact identifier
ndc (product): 69968-0553
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEA-S Medication Solutionsbfb1fdbe-883f-4d1d-9131-a46da98277882024-01-18WarningsExact identifier
ndc (package): 50090-6558-0
ndc (product): 50090-6558
ndc11 (package): 50090655800
spl id: 216ca1cf-0588-4c11-87e4-415273712b46
spl set id: bfb1fdbe-883f-4d1d-9131-a46da9827788

Reported adverse events (FAERS/openFDA)#

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