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 120 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETICS BY RIKI LLC 387d5194-bc12-68c1-e063-6394a90ab152 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sun Protectant TITANIUM DIOXIDE, ZINC OXIDE PANDA PAMPERING LLC 387c23c2-a9f0-f484-e063-6394a90a4104 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sun Protectant TITANIUM DIOXIDE, ZINC OXIDE PANDA PAMPERING LLC 387be96f-8cda-ce02-e063-6394a90abea5 2025-12-15 Exact identifier application number: M020 Serum Lightly Tinted ZINC OXIDE PANDA PAMPERING LLC 387c593b-c65b-62b5-e063-6294a90ac4c2 2025-12-15 Exact identifier application number: M020 Serum Lightly Tinted ZINC OXIDE PANDA PAMPERING LLC 387c9167-638c-1e30-e063-6394a90a9374 2025-12-15 Exact identifier application number: M020 REJUVN8 TITANIUM DIOXIDE, ZINC OXIDE FLEUR DE VIE LLC 37ede476-43b6-a7c8-e063-6294a90a3e8f 2025-12-15 Exact identifier application number: M020 REJUVN8 TITANIUM DIOXIDE, ZINC OXIDE FLEUR DE VIE LLC 37efa5e1-e88e-d251-e063-6394a90a9371 2025-12-15 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE THE BEAUTY ROOM OC INC 3dd330bf-92e4-3664-e063-6294a90a0475 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE THE BEAUTY ROOM OC INC 3dd37dd1-fd43-7af4-e063-6394a90ae3a0 2025-12-15 Warnings Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE THE BEAUTY ROOM OC INC 3dd3dcab-e9fb-0ef5-e063-6394a90acef1 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE THE BEAUTY ROOM OC INC 3dd40a6a-d52e-ab87-e063-6294a90a966e 2025-12-15 Warnings Exact identifier application number: M020 20 Zinc Oxide Non-Tinted Mineral Sunscreen ZINC OXIDE AGELESS SKINCARE INC 3766e6c0-8976-509d-e063-6394a90af00f 2025-12-15 Exact identifier application number: M020 20 Zinc Oxide Tinted Mineral Sunscreen ZINC OXIDE AGELESS SKINCARE INC 3766b00f-ceda-a6f9-e063-6294a90aff5d 2025-12-15 Exact identifier application number: M020 Mattifying Skin Primer TITANIUM DIOXIDE, ZINC OXIDE SKIN MAVEN 37662032-2842-1982-e063-6294a90a49a0 2025-12-15 Exact identifier application number: M020 Moisturizing Face and Body SPF ZINC OXIDE SKIN MAVEN 376645ee-7ea8-e738-e063-6394a90a119b 2025-12-15 Exact identifier application number: M020 Mermaid Glow And Go Non Tinted Mineral Sunscreen ZINC OXIDE Mermaid Glow LLC 3985a298-fe0b-c296-e063-6294a90ab6c0 2025-12-15 Exact identifier application number: M020 Mermaid Glow And Go Non Tinted Mineral Sunscreen ZINC OXIDE Mermaid Glow LLC 39856675-c110-a7a7-e063-6294a90ac6af 2025-12-15 Exact identifier application number: M020 Bio H Plus Daily Defense And Revitalize ZINC OXIDE BIOHEALTH PLUS LLC 3764f723-cc7a-2128-e063-6294a90ac894 2025-12-15 Exact identifier application number: M020 Extreme Protection Non Tinted ZINC OXIDE BIOHEALTH PLUS LLC 37656077-5185-817a-e063-6394a90adf5a 2025-12-15 Exact identifier application number: M020 Deluxe Lip Protection TITANIUM DIOXIDE, ZINC OXIDE BIOHEALTH PLUS LLC 37657895-5fec-82d0-e063-6294a90acf67 2025-12-15 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