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 6 of 361 · 7,213 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Meraki Protective Mist Sunscreen BROAD SPECTRUM SPF 30 MERAKI MEDICAL SPA LLC 59446224-0e97-ae2c-e063-6394a90a2a65 2026-08-17 Warnings Exact identifier application number: M020 Sun Zapper - Acne Pure Zinc Sunscreen SPF50 ZINC OXIDE Veganic SKN Limited 3ee435a5-70fb-0c8a-e063-6394a90a650a 2026-08-16 Warnings Exact identifier application number: M020 Sun Zapper - Anti-ageing pure zinc sunscreen SPF30 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 3f1dc3b2-c289-5996-e063-6394a90ac622 2026-08-16 Warnings Exact identifier application number: M020 ISNTREE HYALURONIC ACID SENSITIVE SUNSCREEN ZINC OXIDE ISNTREE Inc. 58e38665-0bca-fb02-e063-6394a90ad62a 2026-08-13 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Daily Face Sunscreen Broad Spectrum SPF 70 AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATE Kenvue Brands LLC 58d3d390-8b88-a6fe-e063-6394a90a9bf8 2026-08-12 Warnings Exact identifier application number: M020 Neutrogena Clear Face Sunscreen Acne Prone Skin Broad Spectrum SPF 60 AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATE Kenvue Brands LLC 58d7a3e3-b7df-43ce-e063-6294a90a729c 2026-08-12 Warnings Exact identifier application number: M020 HEB 50 Marigold Scent Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B. 58dafa24-24d5-aeb4-e063-6394a90a3c25 2026-08-12 Warnings Exact identifier application number: M020 TESALOVA Coconut SPF 30 Lip Balm SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Tesalova Viktoriia PMU LLC 58dbb9f1-cfb3-62ac-e063-6394a90a6106 2026-08-12 Warnings Exact identifier application number: M020 Elta MD Skincare UV Stick Broad Spectrum SPF50 ZINC OXIDE CP Skin Health Group, Inc 58dd81db-46d4-d763-e063-6394a90abb0b 2026-08-12 Warnings Exact identifier application number: M020 Basin Coconut SPF 30 Lip Balm SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Retail Concepts of Minnesota, Inc. 4a8e93a6-dcf9-3687-e063-6394a90a73ac 2026-08-12 Warnings Exact identifier application number: M020 UV Skin Recovery SPF 50 Red Correcting ZINC OXIDE CP Skin Health Group, Inc. 26e63890-d1af-d171-e063-6394a90af828 2026-08-12 Warnings Exact identifier application number: M020 UV Skin Recovery SPF 50 ZINC OXIDE CP Skin Health Group, Inc. 26d2683f-cfd5-50fd-e063-6394a90a7576 2026-08-12 Warnings Exact identifier application number: M020 doTERRA Sun Body MINERAL SUNSCREEN doTERRA International, LLC 58dcc56f-f093-469c-e063-6394a90a6088 2026-08-12 Warnings Exact identifier application number: M020 Sonage Protec Plus SPF 30 Mineral Sunscreen ZINC OXIDE ASA Universal Inc. dba: Sonage d92fc1df-bbeb-592a-e053-2a95a90a6951 2026-08-12 Warnings Exact identifier application number: M020 Colorescience Total Protection Body Shield Glow ZINC OXIDE Colorescience 52e1d987-a4f8-195e-e063-6294a90a5629 2026-08-11 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 DR. SAMRAO'S OFFICE 58b2ca35-11ed-d848-e063-6294a90a5b37 2026-08-11 Warnings Exact identifier application number: M020 Ciele Tint and Protect ZINC OXIDE Ciele 0162d9c9-07fa-9210-e063-6294a90aa687 2026-08-11 Warnings Exact identifier application number: M020 NeoStrata Skin Active Matrix Support SPF 30 AVOBENZONE, OCTINOXATE, AND OCTISALATE NeoStrata Company Inc. 8e4b9c08-b906-4c5f-a243-55838ae28b90 2026-08-10 Warnings Exact identifier application number: M020 Sunscreen for Kids SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE The Kroger Co. 1c7cd904-ffff-48aa-91bd-cc978946b36a 2026-08-10 Warnings, Adverse reactions Exact identifier application number: M020 Sport Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE The Kroger Co. 22aa46af-5d0f-4256-8f45-be06f6627561 2026-08-10 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