Home NDC 58892-126 Cotz Lip Balm
Product NDC 58892-126
11-digit product format 588920126
Labeler code 58892
Product ID 58892-126_e51f9ed7-389f-4b5b-b9b3-5a408350a7bb
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 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 58892-126-87 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58892-126-87 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58892-126-87 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58892-126-87 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58892-126-87 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58892-126-87 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58892-126-87 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58892-126-87 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58892-126-87 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 58892-126-87 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 58892-126-87 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58892-126-87 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 58892-126-87 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 58892-126-87 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 58892-126-87 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 58892-126-87 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 58892-126-87 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 58892-126-87 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 58892-126-87 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 58892-126-87 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 58892-126-87 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 58892-126-87 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58892-126-87 Cotz Lip Balm Lip Balm/Sunscreen 4.5 g in 1 TUBE LIPSTICK 4.5 2 58892-126-87 Cotz Lip Balm Lip Balm/Sunscreen 1 in 1 CARTON LIPSTICK 1 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Titanium Dioxide ACTIVE INGREDIENT 15FIX9V2JP COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Zinc Oxide ACTIVE INGREDIENT SOI2LOH54Z COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Titanium Dioxide ACTIVE MOIETY 15FIX9V2JP COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Zinc Oxide ACTIVE MOIETY SOI2LOH54Z COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 .Alpha.-Tocopherol INACTIVE INGREDIENT H4N855PNZ1 COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 .ALPHA.-Tocopherol Acetate, D- INACTIVE INGREDIENT A7E6112E4N COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Aluminum Hydroxide INACTIVE INGREDIENT 5QB0T2IUN0 COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Aluminum Oxide INACTIVE INGREDIENT LMI26O6933 COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Aluminum Stearate INACTIVE INGREDIENT U6XF9NP8HM COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Anhydrous Citric Acid INACTIVE INGREDIENT XF417D3PSL COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Ascorbic Acid INACTIVE INGREDIENT PQ6CK8PD0R COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Ascorbyl Palmitate INACTIVE INGREDIENT QN83US2B0N COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 C12-15 Alkyl Benzoate INACTIVE INGREDIENT A9EJ3J61HQ COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Ceresin INACTIVE INGREDIENT Q1LS2UJO3A COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Cetearyl Isononanoate INACTIVE INGREDIENT P5O01U99NI COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Ethylhexyl Palmitate INACTIVE INGREDIENT 2865993309 COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Ferric Oxide Red INACTIVE INGREDIENT 1K09F3G675 COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Ginger Oil INACTIVE INGREDIENT SAS9Z1SVUK COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Hexyldecanol INACTIVE INGREDIENT 151Z7P1317 COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Hexyldecyl Laurate INACTIVE INGREDIENT 0V595C1P6M COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Kiwi Fruit INACTIVE INGREDIENT 71ES77LGJC COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Lecithin, Soybean INACTIVE INGREDIENT 1DI56QDM62 COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Lime (Citrus) INACTIVE INGREDIENT 8CZS546954 COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Polyethylene Glycol 400 INACTIVE INGREDIENT B697894SGQ COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Propylene Glycol Dicaprylate/Dicaprate INACTIVE INGREDIENT O4446S9CRA COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Stearic Acid INACTIVE INGREDIENT 4ELV7Z65AP COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Sunflower Oil INACTIVE INGREDIENT 3W1JG795YI COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58892-126 COTZ LIP BALM LIP BALM/SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.] 2 Legacy NDC, 2 package rows 20130109_a3345cf5-5e48-4052-b5c2-65633869de5a.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 58892-126-87 58892012687 4.5 g in 1 TUBE 4.5 g Historical