Home NDC 58892-354 CoTZ Face Prime and Protect SPF 40 (Tinted)
Product NDC 58892-354
11-digit product format 588920354
Labeler code 58892
Product ID 58892-354_87f5edec-e860-418b-99d8-317d57624d1b
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 2012-06-26
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58892-354-45 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58892-354-45 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 (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 58892-354-45 CoTZ Face Prime and Protect SPF 40 (Tinted) 1 in 1 CARTON CREAM 1 2 58892-354-45 CoTZ Face Prime and Protect SPF 40 (Tinted) 42.5 g in 1 TUBE CREAM 42.5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58892-354 COTZ FACE PRIME AND PROTECT SPF 40 (TINTED) (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] 2 Current NDC, Legacy NDC, 2 package rows 20250124_1088fbf6-5790-490d-b272-ec281b4b76fa.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 160 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 31N OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE Aekyung Industrial Co., Ltd. 43c77b48-18fb-3efe-e063-6294a90ade4b 2025-11-17 Warnings Exact identifier application number: M020 AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 33N OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE Aekyung Industrial Co., Ltd. 43c784ce-3a54-5416-e063-6294a90ac9a2 2025-11-17 Warnings Exact identifier application number: M020 Daily Essential Face Moisturizer ZINC OXIDE Solarium Brands LLC 2a92edc1-04ac-3eda-e063-6294a90ad46d 2025-11-17 Warnings Exact identifier application number: M020 Daily Essential Eye Cream TITANIUM DIOXIDE, ZINC OXIDE Solarium Brands LLC 2a931d9f-4ba8-e3a5-e063-6294a90af780 2025-11-17 Warnings Exact identifier application number: M020 Daily Essential Lip Oil Blushing Nude ZINC OXIDE Solarium Brands LLC 2a93998c-185b-9207-e063-6294a90ab0e9 2025-11-17 Warnings Exact identifier application number: M020 Solarium Daily Essentials Skin Perfecting Primer ZINC OXIDE Solarium Brands LLC 302a02d1-3dc5-2745-e063-6394a90ab6d2 2025-11-17 Warnings Exact identifier application number: M020 Solarium Daily Essentials Luminizing Glow Drops ZINC OXIDE Solarium Brands LLC 302a4efe-d429-b1c4-e063-6294a90a073d 2025-11-17 Warnings Exact identifier application number: M020 Daily Essential Lip Oil Dusty Rose ZINC OXIDE Solarium Brands LLC 2a934860-02a7-a463-e063-6294a90aa446 2025-11-17 Warnings Exact identifier application number: M020 Daily Essential Lip Oil Scarlet Bloom ZINC OXIDE Solarium Brands LLC 2a931e78-e58c-e216-e063-6294a90a3e49 2025-11-17 Warnings Exact identifier application number: M020 Morning Person Daily Repair Protect Moisturizer ZINC OXIDE Morning Person Beauty 33a20264-9216-154e-e063-6294a90a3c8b 2025-11-17 Warnings Exact identifier application number: M020 Banana Boat Baby Mineral Enriched Sunscreen UVA/UVB Protection Broad Spectrum SPF 50PLUS HOMOSALATE,OCTISALATE,OCTOCRYLENE,ZINC OXIDE Edgewell Personal Care Brands LLC c780d5cf-8388-42e0-e053-2a95a90a7c04 2025-11-17 Warnings Exact identifier application number: M020 Hell on Earth The Resistance Daily Face Moisturizer TITANIUM DIOXIDE, ZINC OXIDE Hell on Earth 38debebf-1e12-09f3-e063-6294a90a9a2a 2025-11-17 Warnings Exact identifier application number: M020 BANANA BOAT PROTECTION PLUS VITAMINS FACE SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC e64de59e-b8db-522e-e053-2a95a90ac458 2025-11-17 Warnings Exact identifier application number: M020 Credo Skin Solar Limits Serum ZINC OXIDE Eco-Chic LLC 395dc8eb-978b-a18f-e063-6294a90a2207 2025-11-17 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 05ce5223-3fb2-4c27-e063-6394a90a8a8f 2025-11-17 Warnings Exact identifier application number: M020 Credo Follain Daily Mineral Sunscreen ZINC OXIDE Eco-Chic LLC 395d6ad4-04ae-8945-e063-6294a90ad87c 2025-11-17 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC 0c7b7571-7317-98bc-e063-6294a90aa29f 2025-11-17 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 22717885-d06b-ed2d-e063-6294a90a2118 2025-11-17 Warnings Exact identifier application number: M020 Riversol Daily Glow Mineral Tinted ZINC OXIDE Riversol Skincare 3bc7d94e-e312-a9ca-e063-6394a90a4338 2025-11-17 Warnings Exact identifier application number: M020 Riversol Daily Glow Mineral Untinted ZINC OXIDE Riversol Skincare 3bc78cbb-83e3-7fd6-e063-6394a90a5260 2025-11-17 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 58892-354-45 58892035445 1 TUBE in 1 CARTON (58892-354-45) / 42.5 g in 1 TUBE 1 tube 2021-05-01 0000-00-00 No No Current