Home NDC 58892-348 CoTZ Face Prime and Protect SPF 40 (Non-Tinted)
Product NDC 58892-348
11-digit product format 588920348
Labeler code 58892
Product ID 58892-348_9498c109-3155-481c-a847-975cb655f6bc
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Fallien Cosmeceuticals, LTD
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-11-15
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 80; 38 mg/g; 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 58892-348 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58892-348 58892-348-45 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 Face Prime and Protect SPF 40 (Non-Tinted)
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 80 mg/g ZINC OXIDE 38 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58892-348-45 CoTZ Face Prime and Protect SPF 40 (Non-Tinted) 42.5 g in 1 TUBE CREAM 42.5 2 58892-348-45 CoTZ Face Prime and Protect SPF 40 (Non-Tinted) 1 in 1 CARTON CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58892-348 COTZ FACE PRIME AND PROTECT SPF 40 (NON-TINTED) (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] 2 Current NDC, Legacy NDC, 2 package rows 20250112_f106f52b-2157-46c7-9f7c-50f43a649050.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 44 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TRUST MD SPF30 STEM CELL FACE OCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDE Guangzhou Yapheon Health Industry Co., Ltd. 4f2ca12c-bc6f-61b8-e063-6294a90a0d7e 2026-04-11 Warnings Exact identifier application number: M020 MIDHA Rice Daily Moisture Sun Cream AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE MIDHA Cosmetic Co.,Ltd. 4b394107-7830-c2c6-e063-6294a90a07d9 2026-04-10 Warnings Exact identifier application number: M020 Abib Dewy tinted sunscreen Glow tube Deep OCTISALATE, OCTOCRYLENE, ZINC OXIDE FOURCOMPANY CO., LTD. 4f15d5ba-6396-56bf-e063-6394a90adb06 2026-04-10 Warnings Exact identifier application number: M020 Abib Dewy tinted sunscreen Glow tube Light OCTISALATE, OCTOCRYLENE, ZINC OXIDE FOURCOMPANY CO., LTD. 4f165895-aa84-e215-e063-6394a90a6256 2026-04-10 Warnings Exact identifier application number: M020 Abib Dewy tinted sunscreen Glow tube Medium OCTISALATE, OCTOCRYLENE, ZINC OXIDE FOURCOMPANY CO., LTD. 4f16b8a4-4279-5f79-e063-6294a90a353d 2026-04-10 Warnings Exact identifier application number: M020 Sheer Touch Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE Amazon.com Services LLC f5ca0416-548c-4be0-a69e-c7e1b52aba95 2026-04-10 Warnings, Adverse reactions Exact identifier application number: M020 LASPA TINTED MATTE SUNSCREEN SPF 20 LIGHT ZINC OXIDE The Green Cricket Inc c56fd135-f46a-51ce-e053-2a95a90ab7b3 2026-04-10 Warnings Exact identifier application number: M020 CorTex SunX 50 Thick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CoreTex Products Inc f67a6c6c-c314-1c9d-e053-2a95a90a7f1a 2026-04-10 Warnings Exact identifier application number: M020 Nu Skin 180 Degree UV Block Hydrator SPF 18 OCTINOXATE AND ZINC OXIDE NSE Products, Inc. b9635e59-bb08-4167-b7ba-54c3fc712589 2026-04-09 Warnings Exact identifier application number: M020 Sport Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE The Kroger Co. 79c6fe2a-34c2-44cc-81bc-796c4463d2a6 2026-04-09 Warnings, Adverse reactions Exact identifier application number: M020 Arizona Sun ProductsSurfblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fdbae5-84ec-7b1d-e063-6294a90a2878 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Prickly Pear Lip Balm SPF 15 SUNSCREEN LIP BALM Arizona Sun Products 11e9cb25-6ff8-a121-e063-6394a90a849e 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Sunscreen SPF 8 SUNSCREEN Arizona Sun Products 11e8b612-29be-47ed-e063-6394a90ab9e7 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun ProductsSurfblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fdcfd0-8b24-7efc-e063-6294a90af7fa 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun SPF 45 Cycleblok Sunscreen SUNSCREEN Arizona Sun Products 11e71a84-12d1-2d4f-e063-6294a90adcd6 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun SPF 45 Bikerblok Sunscreen SUNSCREEN Arizona Sun Products 11e6eafd-f967-b748-e063-6394a90aabfd 2026-04-09 Warnings Exact identifier application number: M020 YSE Beauty Skin Glow Primer SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE MSS Beauty LLC 6a318e27-14e5-488e-ac19-010f69cb743d 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Sunscreen Kids Water Resistant SPF 30 SUNSCREEN Arizona Sun Products 116ed17c-3b38-5e96-e063-6294a90a4246 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun SPF 45 Surfblok Sunscreen SUNSCREEN Arizona Sun Products 11e76815-9316-555d-e063-6294a90aeb81 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Moisturizer SPF 3 MOISTURIZER Arizona Sun Products 1171af26-3040-552c-e063-6294a90ae220 2026-04-09 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58892-348-45 58892034845 1 TUBE in 1 CARTON (58892-348-45) / 42.5 g in 1 TUBE 1 tube 2018-11-15 0000-00-00 No No Current