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 132 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Prevention Body ZINC OXIDE NY BEAUTY PALACE LLC 373cef98-a61d-dd36-e063-6394a90a7c3b 2025-12-11 Exact identifier application number: M020 Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly Tinted ZINC OXIDE NY BEAUTY PALACE LLC 373d1e6c-9c32-20f5-e063-6294a90af86f 2025-12-11 Exact identifier application number: M020 Prevention 2 Acne Safe Facial Mineral Sunscreen Non Tinted TITANIUM DIOXIDE, ZINC OXIDE NY BEAUTY PALACE LLC 373c0ab0-8828-542b-e063-6394a90a8633 2025-12-11 Exact identifier application number: M020 Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly Tinted ZINC OXIDE NY BEAUTY PALACE LLC 373ddad0-ed33-a233-e063-6294a90a19cd 2025-12-11 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE SKINPLICITY STUDIO LLC 37263083-b24f-5a71-e063-6294a90aee7d 2025-12-11 Exact identifier application number: M020 Prevention Acne Safe Facial Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE NY BEAUTY PALACE LLC 373d4fad-141c-0904-e063-6394a90a9759 2025-12-11 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE SKINPLICITY STUDIO LLC 37265b3d-92ef-ef4a-e063-6294a90a8d95 2025-12-11 Exact identifier application number: M020 Prevention Body ZINC OXIDE NY BEAUTY PALACE LLC 373d902f-f7b6-298b-e063-6394a90a9307 2025-12-11 Exact identifier application number: M020 Nourish And Defend ZINC OXIDE ANASTASIA FOX-TOMYLOVYCH 3726c177-2912-a6cc-e063-6394a90a0043 2025-12-11 Exact identifier application number: M020 Nourish And Defend ZINC OXIDE ANASTASIA FOX-TOMYLOVYCH 3726f463-7e55-c2a2-e063-6394a90a3c51 2025-12-11 Exact identifier application number: M020 Mattify Total Protection Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37617bd5-c275-aeee-e063-6394a90a214d 2025-12-11 Exact identifier application number: M020 Not YO 80s Zinc Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37644dfd-e96d-a783-e063-6294a90a9796 2025-12-11 Exact identifier application number: M020 Not YO 80s Zinc Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 3762f132-4ab0-74ad-e063-6394a90a436c 2025-12-11 Exact identifier application number: M020 GLOW UP Ageless Daily Protection Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37637e45-c6ed-12ca-e063-6294a90aeb02 2025-12-11 Exact identifier application number: M020 Face and Body Sunscreen ZINC OXIDE SCIENCE CEUTICALS, LLC 369b42f3-5203-87c4-e063-6394a90a6284 2025-12-11 Exact identifier application number: M020 Nourish Non-Tinted Mineral Sunscreen ZINC OXIDE Fern Burg 34a32097-de93-9b1d-e063-6394a90a41df 2025-12-11 Exact identifier application number: M020 Mattify Total Protection Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37641f8b-0133-8bfc-e063-6294a90aac5c 2025-12-11 Exact identifier application number: M020 GLOW UP Ageless Daily Protection Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 3764856a-98c5-334e-e063-6394a90a629d 2025-12-11 Exact identifier application number: M020 Essential Mineral Sun Protection TITANIUM DIOXIDE, ZINC OXIDE Fern Burg 34a360b2-6798-c7e8-e063-6294a90a5cbb 2025-12-11 Exact identifier application number: M020 Nourish Non-Tinted Mineral Sunscreen ZINC OXIDE Fern Burg 34a3e268-e376-11a0-e063-6294a90a46af 2025-12-11 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