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 156 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ATTITUDE Sensitive natural Mineral Sunscreen Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 4495a302-51b9-3bf2-e063-6294a90a7e4f 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral sunscreen Sprayer SPF 50 Watermelon and coco ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44aa1349-e3f1-9b80-e063-6294a90a0fbd 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral sunscreen SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44aaa3c8-ccc4-ae93-e063-6394a90aedc5 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Baby Mineral sunscreen SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44aba591-04da-fe09-e063-6394a90a912a 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral sunscreen SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44aba6d7-7989-0637-e063-6394a90a6c8f 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral sunscreen SPF 50 Tropical coco ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44abca13-8ba9-8925-e063-6294a90accb5 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sensitive natural baby Mineral sunscreen SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44abdfe1-ea6b-a158-e063-6294a90a3eb8 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral sunscreen SPF 50 Watermelon and coco ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44aca1d5-6e0a-def3-e063-6294a90aca26 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral sunscreen SPF 50 Sun kissed vanilla ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44aca181-2a90-20a6-e063-6394a90aff47 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral sunscreen Sprayer SPF 50 Sun kissed vanilla ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44aa529b-2077-3660-e063-6394a90aa405 2025-11-28 Warnings Exact identifier application number: M020 ATTITUDE Sunly Lip Balm SPF 15 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44ad65f0-ec1d-1638-e063-6294a90a2244 2025-11-28 Warnings Exact identifier application number: M020 HOEGOA Hair Scalp Sunscreen Mineral TITANIUM DIOXIDE Guangzhou Hoegoa Biotechnology Co., Ltd. 44b37930-b302-338c-e063-6394a90a5f7f 2025-11-28 Warnings Exact identifier application number: M020 OCEAURA Glitter Sunscreen TITANIUM DIOXIDE Guangzhou Oceaura Biotechnology Co., Ltd. 44b47284-57cd-2e61-e063-6394a90a5072 2025-11-28 Warnings Exact identifier application number: M020 OUHOE Moisturizing And Translucent Sunscreen TITANIUM DIOXIDE Shantou Ouhoe Technology Co., Ltd. 34e8e4a6-2782-9a3d-e063-6394a90a84c2 2025-11-27 Warnings Exact identifier application number: M020 OUHOE Protection Sunscreen TITANIUM DIOXIDE Shantou Ouhoe Technology Co., Ltd. 4272dcef-eda5-1013-e063-6294a90adf38 2025-11-27 Warnings Exact identifier application number: M020 OUHOE Sunscreen TITANIUM DIOXIDE Shantou Ouhoe Technology Co., Ltd. 42fcc9ed-083c-6582-e063-6394a90ae9e6 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Sun Cream TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 305cb87e-450f-840a-e063-6294a90a883f 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Bio Sun Stick TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 349a3d72-9969-855d-e063-6394a90a281c 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Cica Cooling Sun Stick TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 305c13af-0843-f478-e063-6394a90a42de 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Quick Sun Stick Protection Bar TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 3578c958-a457-402b-e063-6394a90a7342 2025-11-27 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