NuGLOW

Product NDC
65113-8503
11-digit product format
651138503
Labeler code
65113
Product ID
65113-8503_f895144d-17fd-4efa-8b05-87f986871753
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTINOXATE, and ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
G.S. COSMECEUTICAL USA, INC.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-10-15
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTINOXATE; ZINC OXIDE
Active strength
1 g/100g; g/100g; g/100g
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 productproduct65113-8503IInactivated by FDA2026-10-15
excluded packagepackage65113-850365113-8503-3IInactivated by FDA2026-10-15

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 packagepackage65113-8503-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65113-8503-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65113-8503-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65113-8503-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65113-8503-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65113-8503-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65113-8503-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65113-8503-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65113-8503-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage65113-8503-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage65113-8503-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage65113-8503-3557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage65113-8503-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage65113-8503-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage65113-8503-31332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage65113-8503-3fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage65113-8503-386f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage65113-8503-3bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage65113-8503-38dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage65113-8503-3e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage65113-8503-39bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage65113-8503-3110d247fa046…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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65113-8503-32019-10-29C16284748780-1960f7f55-c0d4-8e05-e053-dbdaa90a074aNuGLOW ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65113-8503-3NuGLOW DAYTIME THERAPY With SPF 1534 g in 1 JARCREAM341

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXNUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51NUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZNUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXNUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51NUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZNUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RNUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC1NUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
CAMELLIA OLEIFERA LEAFINACTIVE INGREDIENT5077EL0C60NUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UNUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNNUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JNUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATNUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TNUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YNUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08ENUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RNUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65113-8503NUGLOW (AVOBENZONE, OCTINOXATE, AND ZINC OXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1Legacy NDC, 1 package rows20110314_5636a6e4-0747-41a6-9308-fd734784a2e2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
65113-8503-36511385030334 g in 1 JAR34 gHistorical