FDA.reportPublic FDA data

Aveeno Baby continuous protection sensitive skin

Product NDC
69968-0304
11-digit product format
699680304
Labeler code
69968
Product ID
69968-0304_2f7f8556-263b-e99c-e063-6394a90af8ca
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-10-01
Substance
ZINC OXIDE
Active strength
216 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69968-030469968-0304-1DDiscontinued by firm2026-10-27
excluded packagepackage69968-030469968-0304-6DDiscontinued by firm2026-10-27

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 · 19 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0569968-0304-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0569968-0304-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2669968-0304-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2669968-0304-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3169968-0304-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3169968-0304-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2869968-0304-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2869968-0304-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2169968-0304-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2169968-0304-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1069968-0304-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1069968-0304-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3169968-0304-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3169968-0304-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2069968-0304-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1069968-0304-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0869968-0304-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0369968-0304-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0969968-0304-1557ba5c1ecfa…9c80585c8c6e…

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
Aveeno Baby continuous protection sensitive skin
Brand name suffix
Sunscreen Broad Spectrum SPF50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE216 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bbd6710f-a665-437e-b86b-437f732984d1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0304-1Aveeno Baby continuous protection sensitive skinSunscreen Broad Spectrum SPF5014 mL in 1 TUBELOTION1410
69968-0304-3Aveeno Baby continuous protection sensitive skinSunscreen Broad Spectrum SPF5088 mL in 1 TUBELOTION8810
69968-0304-6Aveeno Baby continuous protection sensitive skinSunscreen Broad Spectrum SPF502 in 1 TRAYLOTION210
69968-0304-7Aveeno Baby continuous protection sensitive skinSunscreen Broad Spectrum SPF50207 mL in 1 TUBELOTION20710

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0304AVEENO BABY CONTINUOUS PROTECTION SENSITIVE SKIN SUNSCREEN BROAD SPECTRUM SPF50 (ZINC OXIDE) LOTION [KENVUE BRANDS LLC]10Current NDC, Legacy NDC, 4 package rows20250308_bbd6710f-a665-437e-b86b-437f732984d1.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 161 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BANANA BOATAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC236d2dce-70aa-66d2-e063-6394a90aff522025-11-17WarningsExact identifier
application number: M020
Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Dusky Pink 8gZINC OXIDENAKED SUNDAYS PTY LTD2f441311-b41c-d4e8-e063-6394a90a697a2025-11-17WarningsExact identifier
application number: M020
Woro Beauty SPFortlessTITANIUM DIOXIDE, ZINC OXIDEWoro Beauty3d86ef02-c947-2791-e063-6394a90a42cc2025-11-17WarningsExact identifier
application number: M020
Dolce Glow Body BalmZINC OXIDEDolce Glow, Inc.43cea601-a6c0-4de3-e063-6294a90aa8eb2025-11-17WarningsExact identifier
application number: M020
Hello Sunday The One For Your Lips Clear Lip Balm SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c92dfc3-782d-e11f-e063-6394a90a2f8a2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 33WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d506dd-4103-de3c-e063-6294a90ac1902025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 35NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d5174f-6bd2-1294-e063-6294a90a407b2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 41NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d5299f-6273-30ab-e063-6294a90a082e2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 47NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d53bac-560d-6e4d-e063-6394a90a40c42025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 13COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d55c3d-4550-8131-e063-6394a90a0eed2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 15COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d56169-4843-8546-e063-6294a90a8a102025-11-17WarningsExact identifier
application number: M020
BRING GREEN TEA TREE CICA SUN CUSHIONZINC OXIDE, TITANIUM DIOXIDECJ Olive Young Corporation30850a56-6438-dbe1-e063-6294a90a6d9f2025-11-17WarningsExact identifier
application number: M020
BRING GREEN TEA TREE CICA SUNCREAMZINC OXIDECJ Olive Young Corporation30bdb3c6-2bfa-87c2-e063-6394a90a9a432025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 29COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c73747-82b6-c71c-e063-6294a90aea522025-11-17WarningsExact identifier
application number: M020
Arnies Mineral Sunscreen - Broad Spectrum SPF 50 with Zinc OxideZINC OXIDEGimmie Botanicals LLC43e24a9a-a25c-f011-e063-6394a90abbb22025-11-17WarningsExact identifier
application number: M020
Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Pink Pop 8gZINC OXIDENAKED SUNDAYS PTY LTD2f46049b-7e81-9c7e-e063-6394a90a8f492025-11-14WarningsExact identifier
application number: M020
Huey Daily MineralTITANIUM DIOXIDE, ZINC OXIDEHuey15bdf9c6-3bfa-4eef-e063-6294a90a195f2025-11-14WarningsExact identifier
application number: M020
Pipette Diaper RashZINC OXIDEPipette LLC2a93998c-1855-9207-e063-6294a90ab0e92025-11-14WarningsExact identifier
application number: M020
Ware Sonny UniversalTITANIUM DIOXIDE, ZINC OXIDEWare Cosmeticsfe2b9d16-9215-e21e-e053-6394a90a51562025-11-14WarningsExact identifier
application number: M020
YAY NOVELTY ALL-IN-ONETITANIUM DIOXIDE, ZINC OXIDEYAY Noveltyfb833158-d0d8-de7f-e053-6294a90adc5a2025-11-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0304-16996803040114 mL in 1 TUBE (69968-0304-1) 14 ml2016-10-010000-00-00NoNoCurrent
69968-0304-36996803040388 mL in 1 TUBE (69968-0304-3) 88 ml2016-10-010000-00-00NoNoCurrent
69968-0304-6699680304062 TUBE in 1 TRAY (69968-0304-6) > 88 mL in 1 TUBE (69968-0304-3) 2 tube2019-11-200000-00-00NoNoCurrent
69968-0304-769968030407207 mL in 1 TUBE (69968-0304-7) 207 ml2018-12-010000-00-00NoNoCurrent