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 73 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922e001-e699-7ac5-e063-6394a90a25d9 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Six ZINC OXIDE Clean Beauty For All, Inc (dba Saie) a9350360-7932-459f-806c-399fa265e6c0 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1923067f-1ab9-d168-e063-6394a90adbd0 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five and Half ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922ee84-d7d0-80b1-e063-6394a90acf7b 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Seven ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 310a07bb-d32a-401f-955e-4c2860148a30 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 39ae4a97-7f96-4c95-a6de-0c779764fb02 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four and Half ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922fc3e-055c-e51d-e063-6294a90a00f5 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 9c7a31df-5bdd-403b-b807-1d1a801e1bb6 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade One ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922fc51-ae53-acb8-e063-6394a90a14eb 2026-01-20 Warnings Exact identifier application number: M020 Wrinkle Repair Moisturizer SPF 30 EQB AVOBENZONE 2% HOMOSALATE 4% OCTISALATE 4% OCTOCRYLENE 2% Walmart a067e968-e598-40ef-95f2-c338b5e413dd 2026-01-20 Warnings Exact identifier application number: M020 Welmedix HomeCare PRO Fragile Skin Dual Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Welmedix LLC 48da4589-0f5a-c25b-e063-6394a90ac18b 2026-01-20 Warnings Exact identifier application number: M020 SPF 50 Mineral Sunscreen Kids ZINC OXIDE 14.69% S&C Hampton Sun LLC 0bdb7d15-dc52-4e23-9417-fe73f17f6110 2026-01-20 Warnings Exact identifier application number: M020 DEWYTREE URBAN SHADE INVISIBLE SMOOTHING PORE SUNSTIC SUNSTICK OCTOCRYLENE, HOMOSALATE, ZINC OXIDE, OCTISALATE DEWYTREE CO. ,LTD 48406e68-eefd-d2c2-e063-6394a90a4ad9 2026-01-20 Warnings Exact identifier application number: M020 KONEUK SUNSCREEN SPF50 KONEUK SUNSCREEN SPF50 Guangzhou Meixi Biotechnology Co., Ltd. 48dd7f6e-2a4d-2c92-e063-6294a90a4255 2026-01-20 Warnings Exact identifier application number: M020 CHUDA AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE Premier Ocher LLC 1bc2a2df-a4cd-45e7-93c6-b35dbd8b280f 2026-01-20 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool Fosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 12edec55-2414-4bbd-bc96-4599a96b96ac 2026-01-19 Warnings Exact identifier application number: M020 PROJECT REEF SPF-30 Mineral Sunscreen ZINC OXIDE Project Reef LLC a6077e6f-d987-4159-946f-3e2397247659 2026-01-19 Warnings Exact identifier application number: M020 OUTER REEF MINERAL SUNSCREEN SPF 30 TITANIUM DIOXIDE Coral Reef Park Co., Inc. 86ee2fdf-8a88-44e6-b12a-36a92360477a 2026-01-19 Warnings Exact identifier application number: M020 SABAL Mineral Sunscreen Broad Sprectrum SPF 30 ZINC OXIDE SABAL SUN LLC f917b446-4e10-4231-826e-fdac32e11186 2026-01-19 Warnings Exact identifier application number: M020 Plius Daily SPF Moisturizer SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE PLIUS, Inc 31866de9-afa0-4c11-be65-b61373551493 2026-01-19 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