No7 Restore and Renew Day Sunscreen

Product NDC
11489-078
11-digit product format
114890078
Labeler code
11489
Product ID
11489-078_b4aa84e3-5ad6-44a4-83ed-f9784a63c608
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octisalate, Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
BCM Ltd
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-12-10
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
2 g/50g; g/50g; g/50g
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 productproduct11489-078IInactivated by FDA2026-08-11
excluded packagepackage11489-07811489-078-01IInactivated by FDA2026-08-11

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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01IInactivated 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 packagepackage11489-078-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11489-078-012020-01-31C16284748780-19d75b9d0-9409-f424-e053-dadaa90a57ceNo7 Restore and Renew Day Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11489-078-01No7 Restore and Renew Day Sunscreen1 in 1 CARTONCREAM11
11489-078-01No7 Restore and Renew Day Sunscreen50 g in 1 JARCREAM501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
OCTISALATEACTIVE MOIETY4X49Y0596WNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERINACTIVE INGREDIENTW59H9296ZGNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
ASCORBYL GLUCOSIDEINACTIVE INGREDIENT2V52R0NHXWNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RANO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
CERAMIDE 1INACTIVE INGREDIENT5THT33P7X7NO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
CERAMIDE 3INACTIVE INGREDIENT4370DF050BNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
CERAMIDE 6 IIINACTIVE INGREDIENTF1X8L2B00JNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7JNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BANO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39NO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785INO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
ISOSTEARYL ISOSTEARATEINACTIVE INGREDIENTIV0Z586Z4YNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
MYRISTYL MYRISTATEINACTIVE INGREDIENT4042ZC00DYNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
PALMITOYL OLIGOPEPTIDEINACTIVE INGREDIENTHO4ZT5S86CNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
PALMITOYL TETRAPEPTIDE-7INACTIVE INGREDIENTQ41S464P1RNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
PHYTOSPHINGOSINEINACTIVE INGREDIENTGIN46U9Q2QNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
ROSA MOSCHATA SEED OILINACTIVE INGREDIENTT031ZE559TNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
SODIUM LAUROYL LACTYLATEINACTIVE INGREDIENT7243K85WFONO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8NO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ0NO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
WATERINACTIVE INGREDIENT059QF0KO0RNO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11489-078NO7 RESTORE AND RENEW DAY SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]1Legacy NDC, 2 package rows20121220_744c8142-83c6-4398-a7ca-22c781f4bf6e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11489-078-01114890078011 in 1 CARTONHistorical