Home NDC 58892-418-01 Cotz Sensitive SPF 40
Product NDC 58892-418
Requested package NDC 58892-418-01
11-digit product format 588920418
Labeler code 58892
Product ID 58892-418_42e4a18c-6169-4411-b1b0-918d4cf744e6
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Fallien Cosmeceuticals, LTD.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-03-30
Substance ZINC OXIDE
Active strength 200 mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 20 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Cotz Sensitive SPF 40
Brand name suffix Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 200 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58892-418-01 Cotz Sensitive SPF 40 Sunscreen 100 g in 1 TUBE LOTION 100 2 58892-418-01 Cotz Sensitive SPF 40 Sunscreen 1 in 1 CARTON LOTION 1 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Zinc Oxide ACTIVE INGREDIENT SOI2LOH54Z COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Zinc Oxide ACTIVE MOIETY SOI2LOH54Z COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 .Alpha.-Tocopherol Acetate INACTIVE INGREDIENT 9E8X80D2L0 COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Alkyl (C12-15) Benzoate INACTIVE INGREDIENT A9EJ3J61HQ COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Caprylhydroxamic Acid INACTIVE INGREDIENT UPY805K99W COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Caprylyl Glycol INACTIVE INGREDIENT 00YIU5438U COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Cetyl PEG/PPG-10/1 Dimethicone (HLB 5) INACTIVE INGREDIENT 035JKJ76MT COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Cyclomethicone 5 INACTIVE INGREDIENT 0THT5PCI0R COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Cyclomethicone 6 INACTIVE INGREDIENT XHK3U310BA COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Dimethicone 100 INACTIVE INGREDIENT RO266O364U COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Dimethicone/Diene Dimethicone Crosspolymer INACTIVE INGREDIENT RSA9I561OK COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Edetate Disodium INACTIVE INGREDIENT 7FLD91C86K COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Methicone (20 cst) INACTIVE INGREDIENT 6777U11MKT COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Microcrystalline Wax INACTIVE INGREDIENT XOF597Q3KY COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 PEG-10 Dimethicone (600 cst) INACTIVE INGREDIENT 8PR7V1SVM0 COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 PEG-30 Dipolyhydroxystearate INACTIVE INGREDIENT 9713Q0S7FO COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Polyglyceryl-4 Isostearate INACTIVE INGREDIENT 820DPX33S7 COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Polyhydroxystearic Acid (2300 MW) INACTIVE INGREDIENT YXH47AOU0F COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Polysorbate 20 INACTIVE INGREDIENT 7T1F30V5YH COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Stearyl Dimethicone (400 MPA.S AT 50C) INACTIVE INGREDIENT R327X197HY COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Tetrahexyldecyl Ascorbate INACTIVE INGREDIENT 9LBV3F07AZ COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Triethoxycaprylylsilane INACTIVE INGREDIENT LDC331P08E COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Trolamine INACTIVE INGREDIENT 9O3K93S3TK COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1 Water INACTIVE INGREDIENT 059QF0KO0R COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58892-418 COTZ SENSITIVE SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.] 2 Current NDC, Legacy NDC, 2 package rows 20250406_885a674b-3457-4dfe-a801-529094b00499.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 109 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bella Blue Skin Care Tinted Sunscreen ZINC OXIDE BELLA BLU STUDIOS INC 3f663fe5-fdfe-d793-e063-6394a90a4f0b 2025-12-17 Warnings Exact identifier application number: M020 Tinted Daily Mineral Shield ZINC OXIDE SIGNATURE MED SPA MT LLC 3aadc018-edbb-033b-e063-6394a90afbe7 2025-12-17 Warnings Exact identifier application number: M020 Non-Tinted Daily Mineral Shield ZINC OXIDE SIGNATURE MED SPA MT LLC 3ab0298d-b2d0-591e-e063-6394a90a3177 2025-12-17 Warnings Exact identifier application number: M020 Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE ESTHETICS BY MINDY LLC 3cce3120-748e-a7fd-e063-6394a90a4d51 2025-12-17 Warnings Exact identifier application number: M020 Mineral Sunscreen 20percent Zinc Oxide ZINC OXIDE ESTHETICS BY MINDY LLC 3ccea6c0-8c27-6b26-e063-6294a90a0931 2025-12-17 Warnings Exact identifier application number: M020 Non Tinted Mineral Sunscreen 20Percent Zinc Oxide ZINC OXIDE JKH Aesthetics LLC 369c1d16-5980-e1dc-e063-6394a90a3104 2025-12-17 Exact identifier application number: M020 Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE ESTHETICS BY MINDY LLC 3d5a2662-02e3-3a95-e063-6294a90a8120 2025-12-17 Warnings Exact identifier application number: M020 Mineral Sunscreen 20percent Zinc Oxide ZINC OXIDE ESTHETICS BY MINDY LLC 3d5ab3f6-10b9-2a21-e063-6294a90a3428 2025-12-17 Warnings Exact identifier application number: M020 Daily Defense Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JKH Aesthetics LLC 369ccb8f-d9b6-1fd2-e063-6394a90ace20 2025-12-17 Exact identifier application number: M020 Royal Screen ZINC OXIDE QUEENIES BEAUTY LLC 364cafdd-fe86-cb23-e063-6394a90afb09 2025-12-17 Exact identifier application number: M020 Royal Screen ZINC OXIDE QUEENIES BEAUTY LLC 364d2231-3db3-0a59-e063-6394a90a6777 2025-12-17 Exact identifier application number: M020 Mattifying Mineral SPF40 Tinted TITANIUM DIOXIDE, ZINC OXIDE ELIZA ARAKELIAN 36d4f6a7-1115-1efa-e063-6294a90a20c4 2025-12-17 Exact identifier application number: M020 Replenish SPF 40 ZINC OXIDE ELIZA ARAKELIAN 36d69eb5-597d-14a0-e063-6394a90a0a49 2025-12-17 Exact identifier application number: M020 Mattifying Mineral SPF 40 Tinted TITANIUM DIOXIDE, ZINC OXIDE ELIZA ARAKELIAN 36d45700-fc41-ef54-e063-6394a90abcc3 2025-12-17 Exact identifier application number: M020 Gentle Mineral SPF 40 Tinted ZINC OXIDE ELIZA ARAKELIAN 36d66cde-1f90-32b5-e063-6294a90acb34 2025-12-17 Exact identifier application number: M020 Replenish SPF 40 ZINC OXIDE ELIZA ARAKELIAN 36d7148b-b1c4-a6a9-e063-6294a90af92f 2025-12-17 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d85902-fbd2-ba74-e063-6294a90acfc3 2025-12-17 Exact identifier application number: M020 DAY DEFENSE TITANIUM DIOXIDE, ZINC OXIDE THE SKIN CARE SOURCE, INC. 36ad1330-a8bf-e8f8-e063-6394a90acb02 2025-12-17 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d9a8f3-7760-57f3-e063-6394a90a1a1e 2025-12-17 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d7a18b-5a12-84a9-e063-6394a90a7e38 2025-12-17 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58892-418-01 58892041801 1 TUBE in 1 CARTON (58892-418-01) / 100 g in 1 TUBE 1 tube 2012-03-30 No No Current