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 131 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Non Tinted Mineral Sunscreen ZINC OXIDE SPECKTRA6 LLC 374e1c8e-5c5c-9198-e063-6294a90a3b88 2025-12-11 Exact identifier application number: M020 Non Tinted Mineral Sunscreen ZINC OXIDE SPECKTRA6 LLC 374f063a-1ea6-2fcc-e063-6394a90ac574 2025-12-11 Exact identifier application number: M020 Defend Tinted Mineral SPF 40 TITANIUM DIOXIDE, ZINC OXIDE SMOOTH ESTHETICS LLC 36eb9fc0-25d7-cfb4-e063-6394a90a2e22 2025-12-11 Exact identifier application number: M020 Sheer Tinted Sunscreen SPF40 TITANIUM DIOXIDE, ZINC OXIDE SIMPLICITY SKIN, SPA & BOUTIQUE, LLC 36ebdb85-ce8a-d7e0-e063-6394a90a2261 2025-12-11 Exact identifier application number: M020 Solar Shield Face and Body SPF 40 ZINC OXIDE BRIGHT SKINCARE, LLC 3b138432-19e5-e757-e063-6294a90a4cbe 2025-12-11 Warnings Exact identifier application number: M020 Solar Shield Primer SPF 40 ZINC OXIDE BRIGHT SKINCARE, LLC 3b149758-bbe1-bd66-e063-6294a90afe78 2025-12-11 Warnings Exact identifier application number: M020 Solar Shield Face and Body SPF 40 ZINC OXIDE BRIGHT SKINCARE, LLC 3b14caa3-f58e-b9ab-e063-6394a90a9695 2025-12-11 Warnings Exact identifier application number: M020 Solar Shield Primer SPF 40 ZINC OXIDE BRIGHT SKINCARE, LLC 3b152e27-3917-eb7e-e063-6394a90a1f43 2025-12-11 Warnings Exact identifier application number: M020 Mineral Lip Protection TITANIUM DIOXIDE, ZINC OXIDE COLETTE TOMASI LLC 3727b29f-fe51-0b15-e063-6394a90a780b 2025-12-11 Exact identifier application number: M020 Daytime Moisture SPF40 ZINC OXIDE COLETTE TOMASI LLC 372773b6-fc37-c74b-e063-6294a90a7bf2 2025-12-11 Exact identifier application number: M020 Prevention Acne Safe Facial Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE NY BEAUTY PALACE LLC 373c291a-7839-8486-e063-6294a90a5af3 2025-12-11 Exact identifier application number: M020 Prevention Body ZINC OXIDE NY BEAUTY PALACE LLC 373cef98-a61d-dd36-e063-6394a90a7c3b 2025-12-11 Exact identifier application number: M020 Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly Tinted ZINC OXIDE NY BEAUTY PALACE LLC 373d1e6c-9c32-20f5-e063-6294a90af86f 2025-12-11 Exact identifier application number: M020 Prevention 2 Acne Safe Facial Mineral Sunscreen Non Tinted TITANIUM DIOXIDE, ZINC OXIDE NY BEAUTY PALACE LLC 373c0ab0-8828-542b-e063-6394a90a8633 2025-12-11 Exact identifier application number: M020 Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly Tinted ZINC OXIDE NY BEAUTY PALACE LLC 373ddad0-ed33-a233-e063-6294a90a19cd 2025-12-11 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE SKINPLICITY STUDIO LLC 37263083-b24f-5a71-e063-6294a90aee7d 2025-12-11 Exact identifier application number: M020 Prevention Acne Safe Facial Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE NY BEAUTY PALACE LLC 373d4fad-141c-0904-e063-6394a90a9759 2025-12-11 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE SKINPLICITY STUDIO LLC 37265b3d-92ef-ef4a-e063-6294a90a8d95 2025-12-11 Exact identifier application number: M020 Prevention Body ZINC OXIDE NY BEAUTY PALACE LLC 373d902f-f7b6-298b-e063-6394a90a9307 2025-12-11 Exact identifier application number: M020 Nourish And Defend ZINC OXIDE ANASTASIA FOX-TOMYLOVYCH 3726c177-2912-a6cc-e063-6394a90a0043 2025-12-11 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