Glycolic Day Cream SPF 30

Product NDC
68634-0032
11-digit product format
686340032
Labeler code
68634
Product ID
68634-0032_e8bc0518-5921-4505-99fc-b8c4f30b58c6
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octisalate, Octocrylene, Oxybenzone, Avobenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
AMCOL Health and Beauty Solutions, Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-01-04
Marketing end
0000-00-00
Substance
HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE
Active strength
0 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct68634-0032IInactivated by FDA2026-10-20
excluded packagepackage68634-003268634-0032-2IInactivated 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 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 packagepackage68634-0032-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68634-0032-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68634-0032-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68634-0032-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68634-0032-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68634-0032-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68634-0032-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68634-0032-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68634-0032-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68634-0032-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68634-0032-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68634-0032-2557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68634-0032-28af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68634-0032-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68634-0032-21332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68634-0032-2fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68634-0032-286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68634-0032-2bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68634-0032-28dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68634-0032-2e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68634-0032-29bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68634-0032-2110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68634-0032-22019-10-21C16284748780-1956f9ecf-d9e0-621f-e053-dbdaa90a74adGlycolic Day Cream SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68634-0032-1Glycolic Day Cream SPF 3030 mL in 1 JARCREAM301
68634-0032-2Glycolic Day Cream SPF 301 in 1 BOXCREAM11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOXGLYCOLIC DAY CREAM SPF 30 (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AVOBENZONE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.]1
HomosalateACTIVE INGREDIENTV06SV4M95SGLYCOLIC DAY CREAM SPF 30 (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AVOBENZONE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.]1
OctisalateACTIVE INGREDIENT4X49Y0596WGLYCOLIC DAY CREAM SPF 30 (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AVOBENZONE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.]1
OctocryleneACTIVE INGREDIENT5A68WGF6WMGLYCOLIC DAY CREAM SPF 30 (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AVOBENZONE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.]1
OxybenzoneACTIVE INGREDIENT95OOS7VE0YGLYCOLIC DAY CREAM SPF 30 (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AVOBENZONE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.]1
AvobenzoneACTIVE MOIETYG63QQF2NOXGLYCOLIC DAY CREAM SPF 30 (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AVOBENZONE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.]1
HomosalateACTIVE MOIETYV06SV4M95SGLYCOLIC DAY CREAM SPF 30 (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AVOBENZONE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.]1
OctisalateACTIVE MOIETY4X49Y0596WGLYCOLIC DAY CREAM SPF 30 (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AVOBENZONE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.]1
OctocryleneACTIVE MOIETY5A68WGF6WMGLYCOLIC DAY CREAM SPF 30 (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AVOBENZONE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.]1
OxybenzoneACTIVE MOIETY95OOS7VE0YGLYCOLIC DAY CREAM SPF 30 (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AVOBENZONE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68634-0032GLYCOLIC DAY CREAM SPF 30 (HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AVOBENZONE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.]1Legacy NDC, 2 package rows20100205_cf473fce-9831-4e48-bfc4-e8f8bdd6663b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68634-0032-16863400320130 mL in 1 JAR30 mlHistorical
68634-0032-2686340032021 in 1 BOXHistorical