ALOE SUN BB

Product NDC
76214-046
11-digit product format
762140046
Labeler code
76214
Product ID
76214-046_47b3aadf-1f53-4275-853b-9681da318602
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE
Dosage form
CREAM
Route
TOPICAL
Labeler
SKINFOOD CO., LTD.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-06-01
Marketing end
0000-00-00
Substance
ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE
Active strength
3 g/50g; g/50g; g/50g; g/50g
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct76214-046IInactivated by FDA2026-10-20
excluded packagepackage76214-04676214-046-01IInactivated by FDA2026-10-20

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76214-046-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76214-046-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76214-046-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76214-046-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76214-046-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76214-046-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76214-046-01IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76214-046-01IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76214-046-01IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76214-046-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76214-046-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76214-046-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage76214-046-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage76214-046-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage76214-046-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage76214-046-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage76214-046-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage76214-046-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage76214-046-01IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage76214-046-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage76214-046-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage76214-046-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
76214-046-012020-01-31C16284748780-19d75b9d0-7336-f424-e053-dadaa90a57ce2a71b781-85bf-476b-9d61-6ade59808272

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76214-046-01ALOE SUN BBSPF50 PLUS PA PLUS PLUS PLUS50 g in 1 CARTONCREAM501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51ALOE SUN BB SPF50 PLUS PA PLUS PLUS PLUS (ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [SKINFOOD CO., LTD.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WALOE SUN BB SPF50 PLUS PA PLUS PLUS PLUS (ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [SKINFOOD CO., LTD.]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPALOE SUN BB SPF50 PLUS PA PLUS PLUS PLUS (ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [SKINFOOD CO., LTD.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZALOE SUN BB SPF50 PLUS PA PLUS PLUS PLUS (ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [SKINFOOD CO., LTD.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51ALOE SUN BB SPF50 PLUS PA PLUS PLUS PLUS (ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [SKINFOOD CO., LTD.]1
OCTISALATEACTIVE MOIETY4X49Y0596WALOE SUN BB SPF50 PLUS PA PLUS PLUS PLUS (ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [SKINFOOD CO., LTD.]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPALOE SUN BB SPF50 PLUS PA PLUS PLUS PLUS (ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [SKINFOOD CO., LTD.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37ALOE SUN BB SPF50 PLUS PA PLUS PLUS PLUS (ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [SKINFOOD CO., LTD.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAALOE SUN BB SPF50 PLUS PA PLUS PLUS PLUS (ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [SKINFOOD CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RALOE SUN BB SPF50 PLUS PA PLUS PLUS PLUS (ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [SKINFOOD CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76214-046ALOE SUN BB SPF50 PLUS PA PLUS PLUS PLUS (ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [SKINFOOD CO., LTD.]1Legacy NDC, 1 package rows20140728_2a71b781-85bf-476b-9d61-6ade59808272.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
76214-046-017621400460150 g in 1 CARTON50 gHistorical