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 2027-12-31
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 2027-12-31 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 250 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Walgreens SPF 50 Hydrating AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WALGREEN COMPANY f347588d-8225-45a7-e053-2995a90ab688 2024-12-22 Warnings Exact identifier application number: M020 Mineral Sunstick ZINC SPF STICK Tubby Todd 29e41fe8-4e17-dbaa-e063-6294a90a4a10 2024-12-22 Warnings Exact identifier application number: M020 Mineral Sunscreen ZINC OXIDE SPF 50 Tubby Todd 29e487da-5312-8192-e063-6294a90ad809 2024-12-22 Warnings Exact identifier application number: M020 EcoStick Sunscreen SPF 35 ZINC OXIDE, TITANIUM DIOXIDE Stream2Sea, LLC eba17b7a-5e96-4462-9b71-44c2bc577dce 2024-12-21 Warnings Exact identifier application number: M020 Planet Protecting Sunscreen 30 TITANIUM DIOXIDE Stream2Sea, LLC 89e44c5f-121e-4fdd-b9e0-023909ea32f5 2024-12-21 Warnings Exact identifier application number: M020 BABYGANICS SPF 50 Plus SUNSCREEN ZINC OXIDE, OCTISALATE, AND OCTOCRYLENE KAS Direct LLC dba Babyganics 4075f9dc-c25f-434f-a3fc-a7f896295c3d 2024-12-20 Warnings Exact identifier application number: M020 Sunscreen HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE Total Resources International 7d4f820d-e154-428e-89c2-2e26e088ceef 2024-12-20 Warnings Exact identifier application number: M020 Babyganics Sheer Blend SPF50 Mineral Sunscreen ZINC OXIDE KAS Direct LLC dba BabyGanics edced0dc-dd43-4ac9-b816-f4edb45fc87b 2024-12-20 Warnings Exact identifier application number: M020 NARS Radiance Primer Broad Spectrum SPF 35 Sunscreen OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE COSMAX USA, CORPORATION 29ad7391-d932-3549-e063-6394a90ab2b2 2024-12-20 Warnings Exact identifier application number: M020 Face Reality daily spf 30 plus Sunscreen SPF 30 HOMOSALATE, OCTISALATE, AVOBENZONE Face Reality,LLC 45a3ce12-15fe-4040-95da-ac8513a39fb9 2024-12-20 Warnings Exact identifier application number: M020 Face Reality mineral matte spf 28 Sunscreen SPF 28 ZINC OXIDE, TITANIUM DIOXIDE Face Reality, LLC 29b70afe-cf9d-d0ba-e063-6394a90a1cc4 2024-12-20 Warnings Exact identifier application number: M020 Sonage Roux Tinted Day Creme with SPF 30 Sheer Tinted Moisturizer ZINC OXIDE ASA Universal Inc. dba: Sonage fd14d70c-6cd0-5de6-e053-6294a90a7add 2024-12-20 Warnings Exact identifier application number: M020 Coola SPF 50 Classic SUNSCREEN FACE MIST COOLA LLC d18d0dac-5690-436e-e053-2995a90a0254 2024-12-20 Warnings Exact identifier application number: M020 COOLA Mineral Body SPF 30 Tropical Coconut ZINC OXIDE COOLA, LLC eeb5d4f1-8cba-9ef6-e053-2a95a90a823f 2024-12-20 Warnings Exact identifier application number: M020 Oars and Alps SPF 50 100% Mineral Antioxidant Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Oars and Alps LLC f3971b85-a13e-4195-e053-2995a90a73cb 2024-12-20 Warnings Exact identifier application number: M020 Vacation SPF 30 Mineral ZINC OXIDE Vacation Inc. f69513ae-f210-075f-e053-2a95a90a9b2e 2024-12-20 Warnings Exact identifier application number: M020 Vacation SPF 30 Chardonnay Oil AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Vacation Inc. f694752d-4839-3768-e053-2995a90a5d3e 2024-12-20 Warnings Exact identifier application number: M020 Oars and Alps SPF 50 Hydrating Antioxidant SunscreenSpray AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Oars and Alps LLC ec5b82f5-b36c-fbc5-e053-2995a90afa0c 2024-12-20 Warnings Exact identifier application number: M020 Oars and Alps SPF 70 Hydrating Antioxidant Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Oars and Alps LLC f39673a7-0b62-bdf7-e053-2995a90aa2b7 2024-12-20 Warnings Exact identifier application number: M020 Carpe SPF 30 Face Primer TITANIUM DIOXIDE, ZINC OXIDE Clutch, Inc. DBA Carpe feac5ee2-faa5-fd17-e053-6394a90a7f99 2024-12-20 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