BOTANICS FACE RENEWAL SUNSCREEN SPF 15

Product NDC
11489-057
11-digit product format
114890057
Labeler code
11489
Product ID
11489-057_2d9d5ee4-d733-40c9-a4c2-2d6107135a4d
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE AND AVOBENZONE
Dosage form
CREAM
Route
TOPICAL
Labeler
BCM Ltd
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-02-03
Marketing end
0000-00-00
Substance
OCTINOXATE; AVOBENZONE
Active strength
3 mL/50mL; mL/50mL
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 productproduct11489-057IInactivated by FDA2026-10-12
excluded packagepackage11489-05711489-057-01IInactivated by FDA2026-10-12

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 packagepackage11489-057-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11489-057-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11489-057-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11489-057-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11489-057-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11489-057-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11489-057-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11489-057-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11489-057-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11489-057-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11489-057-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11489-057-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage11489-057-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage11489-057-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage11489-057-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage11489-057-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage11489-057-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage11489-057-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage11489-057-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage11489-057-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage11489-057-019bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage11489-057-01110d247fa046…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
11489-057-012019-10-29C16284748780-1960f7f55-c9c5-8e05-e053-dbdaa90a074aCarton and jar labelling

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11489-057-01BOTANICS FACE RENEWAL SUNSCREEN SPF 1550 mL in 1 JARCREAM501
11489-057-01BOTANICS FACE RENEWAL SUNSCREEN SPF 151 in 1 CARTONCREAM11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51BOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51BOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
BILBERRYINACTIVE INGREDIENT9P2U39H18WBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RABOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8BOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39BOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4BOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
LEMON JUICEINACTIVE INGREDIENTAGN709ANTJBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
MAPLE SYRUPINACTIVE INGREDIENT75UOH57984BOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
POLYOXYL 100 STEARATEINACTIVE INGREDIENTYD01N1999RBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
POMEGRANATEINACTIVE INGREDIENT56687D1Z4DBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
SORBITOLINACTIVE INGREDIENT506T60A25RBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
SUGARCANEINACTIVE INGREDIENT81H2R5AOH3BOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
WATERINACTIVE INGREDIENT059QF0KO0RBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEBOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11489-057BOTANICS FACE RENEWAL SUNSCREEN SPF 15 (OCTINOXATE AND AVOBENZONE) CREAM [BCM LTD]1Legacy NDC, 2 package rows20101208_8c594bb3-826c-48d1-8870-6decd015b6c8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
11489-057-011148900570150 mL in 1 JAR50 mlHistorical