Solar Protection Formula LipTect

Product NDC
58892-240
11-digit product format
588920240
Labeler code
58892
Product ID
58892-240_dbea6f0c-95d1-420f-85ff-b97845ca3018
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
Fallien Cosmeceuticals, LTD.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2004-01-02
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
40 mg/g; mg/g
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 productproduct58892-240IInactivated by FDA2026-10-12
excluded packagepackage58892-24058892-240-45IInactivated 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 packagepackage58892-240-45d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58892-240-45f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58892-240-452ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58892-240-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58892-240-45cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58892-240-45cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58892-240-45302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58892-240-45ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58892-240-450efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58892-240-45ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58892-240-45367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58892-240-45557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage58892-240-458af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage58892-240-45834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage58892-240-451332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage58892-240-45fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage58892-240-4586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage58892-240-45bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage58892-240-458dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage58892-240-45e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage58892-240-459bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage58892-240-45110d247fa046…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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58892-240-452019-11-27C16284748780-19855d018-e4c2-cd31-e053-dbdaa90ab51a0f43b7c6-5e4e-4458-94e2-314e223f9396

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-240-45Solar Protection Formula LipTect Lip Balm/Sunscreen4.5 g in 1 TUBELIPSTICK4.52
58892-240-45Solar Protection Formula LipTect Lip Balm/Sunscreen1 in 1 CARTONLIPSTICK12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPSOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZSOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Titanium DioxideACTIVE MOIETY15FIX9V2JPSOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Zinc OxideACTIVE MOIETYSOI2LOH54ZSOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
.ALPHA.-TocopherolINACTIVE INGREDIENTH4N855PNZ1SOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
.ALPHA.-Tocopherol Acetate, D-INACTIVE INGREDIENTA7E6112E4NSOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Aluminum HydroxideINACTIVE INGREDIENT5QB0T2IUN0SOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Aluminum OxideINACTIVE INGREDIENTLMI26O6933SOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Aluminum StearateINACTIVE INGREDIENTU6XF9NP8HMSOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLSOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Ascorbic AcidINACTIVE INGREDIENTPQ6CK8PD0RSOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Ascorbyl PalmitateINACTIVE INGREDIENTQN83US2B0NSOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
C12-15 Alkyl BenzoateINACTIVE INGREDIENTA9EJ3J61HQSOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
CeresinINACTIVE INGREDIENTQ1LS2UJO3ASOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Cetearyl IsononanoateINACTIVE INGREDIENTP5O01U99NISOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Ethylhexyl PalmitateINACTIVE INGREDIENT2865993309SOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675SOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Ginger OilINACTIVE INGREDIENTSAS9Z1SVUKSOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
HexyldecanolINACTIVE INGREDIENT151Z7P1317SOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Hexyldecyl LaurateINACTIVE INGREDIENT0V595C1P6MSOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Kiwi FruitINACTIVE INGREDIENT71ES77LGJCSOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Lecithin, SoybeanINACTIVE INGREDIENT1DI56QDM62SOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Lime (Citrus)INACTIVE INGREDIENT8CZS546954SOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQSOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Propylene Glycol Dicaprylate/DicaprateINACTIVE INGREDIENTO4446S9CRASOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APSOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2
Sunflower OilINACTIVE INGREDIENT3W1JG795YISOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-240SOLAR PROTECTION FORMULA LIPTECT LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]2Legacy NDC, 2 package rows20121218_0f43b7c6-5e4e-4458-94e2-314e223f9396.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
58892-240-45588920240454.5 g in 1 TUBE4.5 gHistorical