Home NDC 58892-349 CoTZ Mineral Suns Stick - Tinted SPF 45
Product NDC 58892-349
11-digit product format 588920349
Labeler code 58892
Product ID 58892-349_2fb0bd71-d774-4353-b919-743df1fdf3bd
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form STICK
Route TOPICAL
Labeler Fallien Cosmeceuticals, LTD
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-04-01
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 40; 55 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 58892-349 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 58892-349 58892-349-01 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 Mineral Suns Stick - Tinted SPF 45
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 40 mg/g ZINC OXIDE 55 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58892-349-01 CoTZ Mineral Suns Stick - Tinted SPF 45 1 in 1 CARTON STICK 1 2 58892-349-01 CoTZ Mineral Suns Stick - Tinted SPF 45 30 g in 1 CYLINDER STICK 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58892-349 COTZ MINERAL SUNS STICK - TINTED SPF 45 (TITANIUM DIOXIDE, ZINC OXIDE) STICK [FALLIEN COSMECEUTICALS, LTD] 2 Current NDC, Legacy NDC, 2 package rows 20250112_44a6ff9b-8067-4f32-acb2-4ede54c79e6e.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 257 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zinka SPF 30 Clear Sunscreen AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8% Zinka, Inc c054ac39-d03f-17c1-e053-2a95a90aa5ef 2024-12-15 Warnings Exact identifier application number: M020 QC SPF 50 Sunscreen AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% CDMA f82080b1-ef90-a027-e053-6294a90a19f2 2024-12-15 Warnings Exact identifier application number: M020 QC SPF 30 Sunscreen AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6% CDMA f80ceb05-0bd4-1355-e053-6294a90afb19 2024-12-15 Warnings Exact identifier application number: M020 Lip Shine SPF35 Sunscreen ZINC OXIDE Colorescience 3a6506c4-1ba9-493a-a4c8-e5f9c60d221b 2024-12-13 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM DEEP ZINC OXIDE COSMAX USA, CORPORATION 292165af-545d-db43-e063-6394a90ad183 2024-12-13 Warnings Exact identifier application number: M020 Tinted Lip Cream SPF 15 ZINC OXIDE COSMAX USA, CORPORATION 29227121-e579-8eea-e063-6394a90a302f 2024-12-13 Warnings Exact identifier application number: M020 BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,AND OXYBENZONE Bobbi Brown Professional Cosmetics Inc. 03372376-ef03-943d-e063-6394a90a52ee 2024-12-13 Warnings Exact identifier application number: M020 WEIGHTLESS SKIN FOUNDATION BROAD SPECTRUM SPF 15 OCTINOXATE, TITANIUM DIOXIDE Bobbi Brown Professional Cosmetics Inc. fbd04b66-738b-2762-e053-6394a90a8b72 2024-12-13 Warnings Exact identifier application number: M020 Mentholatum Natural Ice Cherry DIMETHICONE, OCTINOXATE, OCTISALATE The Mentholatum Company 33f43f14-8e0b-41b1-8ad0-5723d2a7bf19 2024-12-13 Warnings Exact identifier application number: M020 Absolutely Natural Broad Spectrum SPF 8 Sunscreen ZINC OXIDE Absolutely Natural a26217cf-22ab-4c39-980a-b73467e16b91 2024-12-13 Warnings Exact identifier application number: M020 Calming Primer SPF 20 TITANIUM DIOXIDE AND ZINC OXIDE Colorescience d681cdb5-307e-4a2a-8e1d-2b29131d48d0 2024-12-13 Warnings Exact identifier application number: M020 Absolutely Natural Broad Spectrum SPF 15 Sunscreen ZINC OXIDE Absolutely Natural 8084a3ee-fe31-4cb4-8d3c-e4035d29e561 2024-12-13 Warnings Exact identifier application number: M020 Mineral Corrector Palette SPF 20 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Colorescience ab70122f-bd68-4781-841f-dc83284e1403 2024-12-13 Warnings Exact identifier application number: M020 Neutrogena Healthy Skin Radiant Tinted Moisturizer Sunscreen Broad Spectrum SPF 25, Sheer Ivory 10 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC 0a0654cc-ad47-2167-e063-6294a90a52f4 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals Daily Sheer Mineral Sunscreen SPF 40 ZINC OXIDE, TITANIUM DIOXIDE Babo Botanicals, Inc. f8adda52-e909-1905-e053-6294a90a3c78 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals Swim and Sport Mineral Sunscreen SPF 30 ZINC OXIDE Babo Botanicals, Inc. f8b1ea3a-d62e-e00d-e053-6394a90a5689 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals Swim and Sport Mineral Sunscreen Balm SPF 50 ZINC OXIDE Babo Botanicals, Inc. f8b272f6-8726-de1d-e053-6294a90a7b1e 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals Super Shield Sport Sunscreen SPF 50 ZINC OXIDE Babo Botanicals, Inc. e3ca7840-4882-d605-e053-2a95a90af6ab 2024-12-12 Warnings Exact identifier application number: M020 Babo Botanicals SPF 30 Daily Sheer Tinted Sunscreen - Natural Glow MINERAL SUNSCREEN Babo Botanicals, Inc. ab39d9f0-d869-6f33-e053-2995a90a08d4 2024-12-12 Warnings Exact identifier application number: M020 Alumier MD Sheer Hydration TITANIUM DIOXIDE, ZINC OXIDE Alumier Labs 88dedeb8-963f-5849-e053-2995a90aab72 2024-12-12 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 58892-349-01 58892034901 1 CYLINDER in 1 CARTON (58892-349-01) / 30 g in 1 CYLINDER 1 cylinder 2022-04-01 0000-00-00 No No Current