Shimmery Sun

Product NDC
35192-014
11-digit product format
351920014
Labeler code
35192
Product ID
35192-014_7090373b-0b23-435f-8a24-1ea41c6dc144
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate Titanium Dioxide
Dosage form
LOTION
Route
TOPICAL
Labeler
CA-BOTANA INTERNATIONAL
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-10-10
Marketing end
0000-00-00
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
2 g/113.4g; g/113.4g
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 productproduct35192-014IInactivated by FDA2026-10-12
excluded packagepackage35192-01435192-014-02IInactivated 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 packagepackage35192-014-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35192-014-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35192-014-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35192-014-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35192-014-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35192-014-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35192-014-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35192-014-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35192-014-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35192-014-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35192-014-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35192-014-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage35192-014-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage35192-014-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage35192-014-021332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage35192-014-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage35192-014-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage35192-014-02bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage35192-014-028dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage35192-014-02e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage35192-014-029bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage35192-014-02110d247fa046…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
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35192-014-022019-11-27C16284748780-19855e2a2-35d9-60a7-e053-dbdaa90a05bdSunscreen Shimmery Sun

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35192-014-02Shimmery Sun50 g in 1 TUBELOTION501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
.ALPHA.-BISABOLOL, (+/-)-INACTIVE INGREDIENT36HQN158VCSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
ALANINEINACTIVE INGREDIENTOF5P57N2ZXSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
ALMOND OILINACTIVE INGREDIENT66YXD4DKO9SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
ARGININEINACTIVE INGREDIENT94ZLA3W45FSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESINACTIVE INGREDIENTU72Q2I8C85SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
CETEARYL ISONONANOATEINACTIVE INGREDIENTP5O01U99NISHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
COCONUTINACTIVE INGREDIENT3RT3536DHYSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
GLYCINEINACTIVE INGREDIENTTE7660XO1CSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
GRAPE SEED OILINACTIVE INGREDIENT930MLC8XGGSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
MICAINACTIVE INGREDIENTV8A1AW0880SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
NIACININACTIVE INGREDIENT2679MF687ASHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
OLEA EUROPAEA LEAFINACTIVE INGREDIENTMJ95C3OH47SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
PROPANEDIOLINACTIVE INGREDIENT5965N8W85TSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
ROSA MOSCHATA OILINACTIVE INGREDIENTJ99W255AWFSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
ROSEMARYINACTIVE INGREDIENTIJ67X351P9SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
SORBITANINACTIVE INGREDIENT6O92ICV9RUSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YISHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0RSHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35192-014SHIMMERY SUN (OCTINOXATE TITANIUM DIOXIDE) LOTION [CA-BOTANA INTERNATIONAL]1Legacy NDC, 1 package rows20131027_72aa2113-ed19-49f2-af76-30aefa1a6e78.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
35192-014-023519200140250 g in 1 TUBE50 gHistorical