Home NDC 61354-119 Powder
Product NDC 61354-119
11-digit product format 613540119
Labeler code 61354
Product ID 61354-119_3e142cd6-160d-62f8-e063-6394a90ae70c
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide
Dosage form POWDER
Route TOPICAL
Labeler Oxygen Development LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-27
Substance FERRIC OXIDE RED; TITANIUM DIOXIDE
Active strength 1.75; 10 mg/100mg; mg/100mg
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 Powder
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FERRIC OXIDE RED 1.75 mg/100mg TITANIUM DIOXIDE 10 mg/100mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1K09F3G675 Internal UNII lookup 15FIX9V2JP 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 61354-119-01 Powder 100 mg in 1 CUP POWDER 100 3 61354-119-02 Powder 1 in 1 CARTON POWDER 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-119 POWDER (TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT LLC] 2 Current NDC, 2 package rows 20250508_08b8003f-40be-3380-e063-6294a90a4f6b.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 324 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Personalized Day Moisturizer with SPF TITANIUM DIOXIDE, ZINC OXIDE Proven Skincare 3b6546ed-22ee-48e6-83cc-5cbadf567499 2023-11-10 Warnings Exact identifier application number: M020 Proven Personalized Day Moisturizer With SPF 50 ZINC OXIDE Proven Skincare ba9b3cdc-c237-7ce2-e053-2995a90ac175 2023-11-10 Warnings Exact identifier application number: M020 MIAMI BEACH BUM Save Face SPF-30 Sunscreen ZINC OXIDE MIAMI BEACH BUM 538742bc-d8f3-47d9-a85f-f2b1314f5507 2023-11-10 Warnings Exact identifier application number: M020 Tropical Sands SPF-30 Broad Spectrum Sunscreen (Coconut) TITANIUM DIOXIDE, ZINC OXIDE Elements Brands, Inc. 4935f888-cd92-61d1-e054-00144ff8d46c 2023-11-10 Warnings Exact identifier application number: M020 Coral Safe SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Elements Brands, Inc. 4925a507-863f-1088-e054-00144ff8d46c 2023-11-10 Warnings Exact identifier application number: M020 CoralSafe Broad Spectrum SPF30 TITANIUM DIOXIDE, ZINC OXIDE Elements Brands e6e00896-b7e5-41c6-a72b-08e600758cf5 2023-11-10 Warnings Exact identifier application number: M020 Coral Safe SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Elements Brands, Inc. 4925a3ad-6379-108a-e054-00144ff8d46c 2023-11-10 Warnings Exact identifier application number: M020 BELASOL Sun Cream Non-Tinted Moisturizing SPF 50 TITANIUM DIOXIDE, ZINC OXIDE EK Clothing LLC dba Belasol fb677ad0-2791-44ec-9720-951471ec009a 2023-11-09 Warnings Exact identifier application number: M020 Shaklee Youth Age Defense Mineral Moisturizer SPF 30 TITANIUM DIOXIDE Shaklee Corporation f4888fdc-09f9-43de-8c81-5a0f5e767d4e 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Eco 30 Broad Spectrum SPF 30 ZINC OXIDE Raw Elements LLC bcce6d5b-d641-4484-a4dd-06b81170f863 2023-11-09 Warnings Exact identifier application number: M020 Spit and Polish Mineral Face SPF 30 ZINC OXIDE Naturally Uncommon, LLC af86fca8-571c-0cac-e053-2a95a90ae402 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Tint 30 Broad Spectrum SPF 30 ZINC OXIDE Raw Elements LLC 801a616a-5007-4951-8bc5-b8ffe9f0bb19 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Baby Kids Broad Spectrum SPF30 ZINC OXIDE Raw Elements LLC fda8fce8-a164-45b5-b6ca-b1efce474089 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Lip Rescue 30 Broad Spectrum SPF 30 ZINC OXIDE Raw Elements LLC 74b8eac3-4bc6-430b-b4b9-eabe3280d7af 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Baby Kids Broad Spectrum SPF30 Sunscreen ZINC OXIDE Raw Elements LLC a6e5f808-65c7-4810-a15c-413111216dae 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Eco Formula 30 Broad Spectrum SPF 30 ZINC OXIDE Raw Elements LLC 1d130543-9e12-42f4-80b4-915dbe0f85d4 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Facial Moisturizer Tint Formula 30 SPF 30 Broad Spectrum ZINC OXIDE Raw Elements LLC 8aff5517-8b3d-490e-b821-973baea2d079 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Daily Moisturizer Broad Spectrum SPF30 ZINC OXIDE Raw Elements LLC 92c5f11b-5585-4479-8ee3-315c7e72574f 2023-11-09 Warnings Exact identifier application number: M020 Big Mood SPF 30 Milky Lip Balm ZINC OXIDE Everyday Group Limited c83098af-3cf9-78f6-e053-2995a90a0d01 2023-11-09 Warnings Exact identifier application number: M020 Spit and Polish Sun Smart Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Naturally Uncommon, LLC af879a05-1483-5c11-e053-2995a90af45d 2023-11-09 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 61354-119-01 61354011901 100 mg in 1 CUP 100 mg Historical 61354-119-02 61354011902 1 CUP in 1 CARTON (61354-119-02) / 100 mg in 1 CUP (61354-119-01) 1 cup 2023-10-27 No No Current