FDA.reportPublic FDA data

Neutrogena Oil Free Moisture Broad Spectrum SPF15

Product NDC
69968-0616
11-digit product format
699680616
Labeler code
69968
Product ID
69968-0616_42264a61-1034-3a99-e063-6294a90a9595
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octisalate, Octocrylene, and Oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-21
Substance
OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
40; 15; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69968-061669968-0616-4DDiscontinued by firm2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69968-061669968-0616-4DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69968-061669968-0616-4DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Neutrogena Oil Free Moisture Broad Spectrum SPF15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBENZONE40 mg/mL
AVOBENZONE15 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
95OOS7VE0YInternal UNII lookup
G63QQF2NOXInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
18303bc2-2e00-4a9e-900f-86397ca9d163Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0616-2Neutrogena Oil Free Moisture Broad Spectrum SPF1550 mL in 1 TUBELOTION5010
69968-0616-4Neutrogena Oil Free Moisture Broad Spectrum SPF15118 mL in 1 BOTTLELOTION11810
69968-0616-4Neutrogena Oil Free Moisture Broad Spectrum SPF151 in 1 CARTONLOTION110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0616NEUTROGENA OIL FREE MOISTURE BROAD SPECTRUM SPF15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [KENVUE BRANDS LLC]9Current NDC, Legacy NDC, 3 package rows20241115_18303bc2-2e00-4a9e-900f-86397ca9d163.zip

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 95 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eucerin Oil-Control SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccda04484-ba84-2276-e053-2a95a90a41c82025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc240dd76a-8f39-caec-e063-6294a90abbbc2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan SPF 30AVOBENZONE 3%, HOMOSALATE 14%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3994886-2ebe-a9d2-e053-2995a90aaf9a2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3d471b8-7430-98b0-e053-2995a90aba4b2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc241f78be-0d7f-c5ca-e063-6294a90a997a2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdort Incd39a009d-1f33-88bb-e053-2a95a90a03a02025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd460d669-42df-46c0-e053-2a95a90ad77b2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 8AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incd370094c-3373-594b-e053-2a95a90a114a2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15(TO DELIVER) AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inc0a5a35be-9e24-18dd-e063-6394a90a097f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd462081f-f082-5df2-e053-2995a90aa1d92025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3e66496-bc3c-d189-e053-2a95a90a06b62025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc.c05388dc-4282-ee79-e053-2a95a90a376a2025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incb60dcbd1-42d0-646f-e053-2a95a90a497d2025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd474fea9-65a7-672b-e053-2a95a90ab9892025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 40AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Incd4d9ad73-6394-2391-e053-2a95a90a2df62025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 100AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incdf498e82-e1c9-51eb-e053-2a95a90a49b62025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incd3984138-763b-1002-e053-2995a90acefc2025-12-31WarningsExact identifier
application number: M020
Coppertone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Incd8b0d5ad-a82c-5304-e053-2a95a90afa632025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incd8d80a15-8282-a18e-e053-2a95a90a2c6c2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd915cb28-2813-5a38-e053-2a95a90a45c62025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0616-26996806160250 mL in 1 TUBE (69968-0616-2) 50 ml2020-04-290000-00-00NoNoCurrent
69968-0616-4699680616041 BOTTLE in 1 CARTON (69968-0616-4) > 118 mL in 1 BOTTLE1 bottle2019-06-210000-00-00NoNoCurrent