FDA.reportPublic FDA data

Neutrogena

Manufacturer
Kenvue Brands LLC
Effective date
2026-09-10
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
daily-update
Hydrated at
2026-09-12 01:01:41

Label at a glance#

ProductNeutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
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

spray liberally and spread evenly by hand 15 minutes before sun exposure hold container 4-6 inches from the skin to apply. Rub in. do not spray directly into face. Spray on hands and then apply to face. Rub in. do not apply in windy conditions use in a well-ventilated area reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures. Spending time ...

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.
  • keep away from face to avoid breathing it

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

SPL UNCLASSIFIED SECTION

  • Warning: Flammable. Contents under pressure. Do not use near fire, heat or while smoking. Do not puncture or incinerate. Store at temperature below 120°F (48°C). Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions

DOSAGE & ADMINISTRATION SECTION

  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4-6 inches from the skin to apply. Rub in.
  • do not spray directly into face. Spray on hands and then apply to face. Rub in.
  • do not apply in windy conditions
  • use in a well-ventilated area
  • 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

Alcohol Denat., Isobutane, Dicaprylyl Carbonate, Polyester-7, Acrylates/Octylacrylamide Copolymer, Neopentyl Glycol Diheptanoate, Fragrance, Tocopheryl Acetate

Questions or Comments?

OTC - QUESTIONS SECTION

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

www.neutrogena.com

SPL UNCLASSIFIED SECTION

Distributed by:

Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 141 g Can Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW LOOK

Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND

ULTRA

SHEER ®

Body Mist

Sunscreen

45

BROAD SPECTRUM SPF 45

Antioxidant Vitamin E

Lightweight clean feel

Shields skin 6 layers deep

with HELIOPLEX ®

Water resistant (80 minutes)

NET WT 5.0 OZ (141 g)

Neutrogena_1Neutrogena_1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130086800100393GTIN-13: 0086800100393
EAN-13: 0086800100393
GTIN-12: 086800100393
UPC-A: 086800100393
GTIN storage (14 digits): 00086800100393		Neutrogena_1.jpg
Data codeData Matrix30061185Neutrogena_1.jpg

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-057969968-0579-8, 69968-0579-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ALCOHOL3K9958V90MIACT
ISOBUTANEBXR49TP611IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
POLYESTER-70841698D2FIACT
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)JU3XHR8VWKIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112025-07-18full-release2026-06-01 01:08:27

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 Body Mist Sunscreen Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC51f3d6ca-3189-4380-9afb-4259ba8782742026-09-10WarningsExact identifier
ndc (package): 69968-0579-8
ndc (package): 69968-0579-5
ndc (product): 69968-0579
ndc11 (package): 69968057908
ndc11 (package): 69968057905
spl id: 5b1cfad8-ac9a-b950-e063-6294a90a7433
spl set id: 51f3d6ca-3189-4380-9afb-4259ba878274

Reported adverse events (FAERS/openFDA)#

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