Botanics Skin Calming Day Ultra Calm Sunscreen Broad Spectrum SPF 15

Product NDC
11489-081
11-digit product format
114890081
Labeler code
11489
Product ID
11489-081_cd9a29cc-a2d2-4eed-8da7-952777c2e94a
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
2013-01-14
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 productproduct11489-081IInactivated by FDA2026-09-14
excluded packagepackage11489-08111489-081-01IInactivated by FDA2026-09-14

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 packagepackage11489-081-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11489-081-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11489-081-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11489-081-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11489-081-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11489-081-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11489-081-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11489-081-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11489-081-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11489-081-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11489-081-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11489-081-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage11489-081-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage11489-081-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage11489-081-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage11489-081-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage11489-081-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage11489-081-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage11489-081-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage11489-081-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage11489-081-019bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage11489-081-01110d247fa046…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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11489-081-012019-11-27C16284748780-19855d018-e219-cd31-e053-dbdaa90ab51a0d4986d4-a429-4a97-9d23-6a903e167cda

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11489-081-01Botanics Skin Calming Day Ultra Calm Sunscreen Broad Spectrum SPF 151 in 1 CARTONCREAM12
11489-081-01Botanics Skin Calming Day Ultra Calm Sunscreen Broad Spectrum SPF 1550 g in 1 JARCREAM502

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
OCTISALATEACTIVE INGREDIENT4X49Y0596WBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
AVOBENZONEACTIVE MOIETYG63QQF2NOXBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
OCTISALATEACTIVE MOIETY4X49Y0596WBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
ALTHAEA OFFICINALIS ROOTINACTIVE INGREDIENTTRW2FUF47HBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
CETEARYL GLUCOSIDEINACTIVE INGREDIENT09FUA47KNABOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40BOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
ISOSTEARYL ISOSTEARATEINACTIVE INGREDIENTIV0Z586Z4YBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UTBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4BOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
SODIUM POLYACRYLATE (8000 MW)INACTIVE INGREDIENT285CYO341LBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
SORBITOLINACTIVE INGREDIENT506T60A25RBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
TILIA CORDATA FLOWERINACTIVE INGREDIENTCFN6G1F6YKBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ0BOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2
WATERINACTIVE INGREDIENT059QF0KO0RBOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11489-081BOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) CREAM [BCM LTD]2Legacy NDC, 2 package rows20130114_0d4986d4-a429-4a97-9d23-6a903e167cda.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11489-081-01114890081011 in 1 CARTONHistorical