Baby SPF 60 Sunscreen

Product NDC
0363-3216
11-digit product format
003633216
Labeler code
0363
Product ID
0363-3216_fc8944eb-b2e3-48c6-a6d0-14acc2580e07
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide - 6.00% Zinc Oxide - 4.70%
Dosage form
STICK
Route
TOPICAL
Labeler
Walgreens
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-02-13
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
6 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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 productproduct0363-3216IInactivated by FDA2026-10-05
excluded packagepackage0363-32160363-3216-01IInactivated by FDA2026-10-05

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-3216-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-3216-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-3216-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-3216-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-3216-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-3216-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-3216-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-3216-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-3216-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-3216-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0363-3216-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0363-3216-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage0363-3216-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage0363-3216-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0363-3216-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0363-3216-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0363-3216-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0363-3216-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0363-3216-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0363-3216-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0363-3216-019bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-3216-012020-01-31C16284748780-19d75b9d0-c04c-f424-e053-dadaa90a57ceWalgreens Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-3216-01Baby SPF 60 Sunscreen14.2 g in 1 BOTTLESTICK14.22

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPBABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]1
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZBABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPBABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]1
ZINC CATIONACTIVE MOIETY13S1S8SF37BABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]1
Aluminum HydroxideINACTIVE INGREDIENT5QB0T2IUN0BABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KBABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]1
Butyloctyl SalicylateINACTIVE INGREDIENT2EH13UN8D3BABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]1
C12-15 Alkyl BenzoateINACTIVE INGREDIENTA9EJ3J61HQBABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]1
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19BABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]1
CERESININACTIVE INGREDIENTQ1LS2UJO3ABABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]1
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNBABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1OBABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7BABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]1
Isostearic AcidINACTIVE INGREDIENTX33R8U0062BABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]1
Neopentyl Glycol DiethylhexanoateINACTIVE INGREDIENTU68ZV6W62CBABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]1
ParaffinINACTIVE INGREDIENTI9O0E3H2ZEBABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APBABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]1
TriethoxycaprylylsilaneINACTIVE INGREDIENTLDC331P08EBABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VBABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-3216BABY SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [WALGREENS]2Legacy NDC, 1 package rows20180215_af8cce4d-23a2-47e4-8b5a-8c49e458d01b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0363-3216-010036332160114.2 g in 1 BOTTLE14.2 gHistorical