FDA.reportPublic FDA data

Titanium Dioxide, Zinc Oxide

Manufacturer
Kenvue Brands LLC
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:42:41

Label at a glance#

ProductNeutrogena Healthy Skin Radiant Tinted Moisturizer Sunscreen Broad Spectrum SPF 25, Sheer Ivory 10
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure12 sections

Indications and uses

helps prevent sunburn

Dosage and administration

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating children under 6 months of age: Ask a doctor

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
Titanium Dioxide (6%)Sunscreen
Zinc Oxide (9.28%)Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert:

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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 at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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, C12-15 Alkyl Benzoate, Butylene Glycol, Ethylhexyl Palmitate, Butyloctyl Salicylate, Glyceryl Stearate, PEG-100 Stearate, Cetyl Dimethicone, Cetearyl Alcohol, Polyhydroxystearic Acid, Silica, Phenoxyethanol, Alumina, Aluminum Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Tocopherol, Barium Sulfate, Bisabolol, Squalane, Triethoxycaprylylsilane, Magnesium Aluminum Silicate, Polysorbate 20, Dipotassium Glycyrrhizate, Xanthan Gum, Cetyl Hydroxyethylcellulose, Trisodium Ethylenediamine Disuccinate, Polysorbate 60, Ethylhexylglycerin, Ascorbic Acid, Titanium Dioxide, Iron Oxides

Questions?

OTC - QUESTIONS SECTION

800-480-4812; Outside US, dial collect 215-273-8755 www.neutrogena.com

SPL UNCLASSIFIED SECTION

Distributed by:
Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 32 mL Tube Label - sheer ivory 10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RADIANT

TINTED

MOISTURIZER

HEALTHY SKIN

sunscreen

SPF 25

with Vitamin C & E

SHEER IVORY 10

Neutrogena ®

NET WT. 1.1 FL OZ. (32ML)

08300830

PRINCIPAL DISPLAY PANEL - 32 mL Tube Label - sheer fair 20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RADIANT

TINTED

MOISTURIZER

HEALTHY SKIN

sunscreen

SPF 25

with Vitamin C & E

SHEER FAIR 20

Neutrogena ®

NET WT. 1.1 FL OZ. (32ML)

08310831

PRINCIPAL DISPLAY PANEL - 32 mL Tube Label - sheer tan 30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RADIANT

TINTED

MOISTURIZER

HEALTHY SKIN

sunscreen

SPF 25

with Vitamin C & E

SHEER TAN 30

Neutrogena ®

NET WT. 1.1 FL OZ. (32ML)

08320832

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0830-1Neutrogena Healthy Skin Radiant Tinted Moisturizer Sunscreen Broad Spectrum SPF 25, Sheer Ivory 1032 mL in 1 TUBELOTION323
69968-0831-1Neutrogena Healthy Skin Radiant Tinted Moisturizer Sunscreen Broad Spectrum SPF 25, Sheer Fair 2032 mL in 1 TUBELOTION323
69968-0832-1Neutrogena Healthy Skin Radiant Tinted Moisturizer Sunscreen Broad Spectrum SPF 25, Sheer Tan 3032 mL in 1 TUBELOTION323

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0830NEUTROGENA HEALTHY SKIN RADIANT TINTED MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 25, SHEER IVORY 10 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION NEUTROGENA HEALTHY SKIN RADIANT TINTED MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 25, SHEER TAN 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION NEUTROGENA HEALTHY SKIN RADIANT TINTED MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 25, SHEER FAIR 20 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [KENVUE BRANDS LLC]3Current NDC, 1 package rows20241215_0a0654cc-ad47-2167-e063-6294a90a52f4.zip
69968-0831NEUTROGENA HEALTHY SKIN RADIANT TINTED MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 25, SHEER IVORY 10 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION NEUTROGENA HEALTHY SKIN RADIANT TINTED MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 25, SHEER TAN 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION NEUTROGENA HEALTHY SKIN RADIANT TINTED MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 25, SHEER FAIR 20 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [KENVUE BRANDS LLC]3Current NDC, 1 package rows20241215_0a0654cc-ad47-2167-e063-6294a90a52f4.zip
69968-0832NEUTROGENA HEALTHY SKIN RADIANT TINTED MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 25, SHEER IVORY 10 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION NEUTROGENA HEALTHY SKIN RADIANT TINTED MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 25, SHEER TAN 30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION NEUTROGENA HEALTHY SKIN RADIANT TINTED MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 25, SHEER FAIR 20 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [KENVUE BRANDS LLC]3Current NDC, 1 package rows20241215_0a0654cc-ad47-2167-e063-6294a90a52f4.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-083069968-0830-1
69968-083269968-0832-1
69968-083169968-0831-1

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 90 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
TOCOPHEROLR0ZB2556P8IACT
POLYSORBATE 207T1F30V5YHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMERAE7QA6TW0QIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ETHYLHEXYL PALMITATE2865993309IACT
PEG-100 STEARATEYD01N1999RIACT
BARIUM SULFATE25BB7EKE2EIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
FERRIC OXIDE RED1K09F3G675IACT
SQUALANEGW89575KF9IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALUMINUM STEARATEU6XF9NP8HMIACT
ALUMINUM OXIDELMI26O6933IACT
LEVOMENOL24WE03BX2TIACT
XANTHAN GUMTTV12P4NEEIACT
POLYSORBATE 60CAL22UVI4MIACT
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
TOCOPHEROLR0ZB2556P8IACT
POLYSORBATE 207T1F30V5YHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMERAE7QA6TW0QIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ETHYLHEXYL PALMITATE2865993309IACT

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 Healthy Skin Radiant Tinted Moisturizer Sunscreen Broad Spectrum SPF 25, Sheer Ivory 10TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC0a0654cc-ad47-2167-e063-6294a90a52f42024-12-12WarningsExact identifier
ndc (package): 69968-0832-1
ndc (package): 69968-0831-1
ndc (package): 69968-0830-1
ndc (product): 69968-0832
ndc (product): 69968-0830
ndc (product): 69968-0831
ndc11 (package): 69968083201
ndc11 (package): 69968083001
ndc11 (package): 69968083101
spl id: 2911d917-470f-9948-e063-6294a90ae5ef
spl set id: 0a0654cc-ad47-2167-e063-6294a90a52f4

Reported adverse events (FAERS/openFDA)#

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