No7 Rebalancing Day Fluid Sunscreen SPF 15

Product NDC
11489-069
11-digit product format
114890069
Labeler code
11489
Product ID
11489-069_eff82fba-618b-4299-8245-919d41d08967
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate and Avobenzone and Ensulizole
Dosage form
LOTION
Route
TOPICAL
Labeler
BCM Ltd
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2009-12-04
Marketing end
0000-00-00
Substance
OCTINOXATE; AVOBENZONE; ENSULIZOLE
Active strength
6 mL/100mL; mL/100mL; mL/100mL
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 productproduct11489-069IInactivated by FDA2026-10-05
excluded packagepackage11489-06911489-069-01IInactivated 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 · 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 packagepackage11489-069-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11489-069-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11489-069-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11489-069-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11489-069-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11489-069-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11489-069-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11489-069-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11489-069-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11489-069-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11489-069-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11489-069-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage11489-069-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage11489-069-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage11489-069-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage11489-069-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage11489-069-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage11489-069-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage11489-069-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage11489-069-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage11489-069-019bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage11489-069-01110d247fa046…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
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11489-069-012019-10-29C16284748780-1960f7f55-c07d-8e05-e053-dbdaa90a074aCarton and bottle labelling

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11489-069-01No7 Rebalancing Day Fluid Sunscreen SPF 151 in 1 CARTONLOTION11
11489-069-01No7 Rebalancing Day Fluid Sunscreen SPF 15100 mL in 1 BOTTLE, PUMPLOTION1001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
ENSULIZOLEACTIVE INGREDIENT9YQ9DI1W42NO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51NO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
ENSULIZOLEACTIVE MOIETY9YQ9DI1W42NO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51NO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
ALANINEINACTIVE INGREDIENTOF5P57N2ZXNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
ARGININEINACTIVE INGREDIENT94ZLA3W45FNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
BETAINEINACTIVE INGREDIENT3SCV180C9WNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BANO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39NO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
GLUTAMIC ACIDINACTIVE INGREDIENT3KX376GY7LNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
GLYCINEINACTIVE INGREDIENTTE7660XO1CNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
LYSINEINACTIVE INGREDIENTK3Z4F929H6NO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
PROLINEINACTIVE INGREDIENT9DLQ4CIU6VNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
SERINEINACTIVE INGREDIENT452VLY9402NO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A2NO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
SORBITOLINACTIVE INGREDIENT506T60A25RNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
THREONINEINACTIVE INGREDIENT2ZD004190SNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
WATERINACTIVE INGREDIENT059QF0KO0RNO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11489-069NO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE AND ENSULIZOLE) LOTION [BCM LTD]1Legacy NDC, 2 package rows20101202_c08b16e2-4e97-449a-bd9d-da3ad0158eaf.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11489-069-01114890069011 in 1 CARTONHistorical