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 2026-12-31
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 2026-12-31 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 177 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Thrive Daily Defense Sunscreen Balm SPF30 ZINC OXIDE Thrive Natural Care, Inc 1266bd05-1971-a7f0-e063-6394a90a089c 2025-10-17 Warnings Exact identifier application number: M020 AESOP Avail Body Sunscreen Broad Spectrum SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE Emeis Cosmetics Pty Ltd 2cb40521-94ed-4e76-a4e2-de1c80155bd2 2025-10-17 Warnings Exact identifier application number: M020 AESOP Avail Facial Sunscreen Broad Spectrum SPF 25 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Emeis Cosmetics Pty Ltd bff60c2f-0cc6-493b-81a0-ed35e9746146 2025-10-17 Warnings Exact identifier application number: M020 Mineral Lip Balm Pineapple ZINC OXIDE Synchronicity Spa, Inc. DBA Suntegrity 667714f6-38bc-4c94-aacc-24b46e8e59fd 2025-10-17 Warnings Exact identifier application number: M020 ELEVEN BY VENUS WILLIAMS GAME SET MATCH BODY ZINC OXIDE Eco-Chic LLC dd2fe82e-31e1-1349-e053-2995a90aa409 2025-10-16 Warnings Exact identifier application number: M020 Hello Bello Kids SPF 50 Face and Body Sunscreen Stick ZINC OXIDE Hello Bello 4127e49a-eb27-e8e2-e063-6294a90a469e 2025-10-16 Warnings Exact identifier application number: M020 ELEVEN UNRIVALED SERUM ZINC OXIDE Eco Chic, LLC f4bdacb9-bedd-c9cc-e053-2995a90a5786 2025-10-16 Warnings Exact identifier application number: M020 ELEVEN BY VENUS WILLIAMS ACE THE DAY Face ZINC OXIDE Eco-Chic LLC de438665-72d9-9b1b-e053-2a95a90ab9ef 2025-10-16 Warnings Exact identifier application number: M020 Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 6bb07f16-c3a3-49e7-ae13-718bb0055873 2025-10-16 Warnings Exact identifier application number: M020 Illuminizing Blendrops Broad Spectrum SPF 40 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 124e6702-97a4-95bf-e063-6394a90afc0d 2025-10-16 Warnings Exact identifier application number: M020 Perfecting Blendrops Broad Spectrum SPF 46 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 414c1186-6f68-3828-e063-6294a90a66cf 2025-10-16 Warnings Exact identifier application number: M020 Bronzing Blendrops Broad Spectrum SPF 46 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 414c2db8-3122-60d3-e063-6394a90ae1c8 2025-10-16 Warnings Exact identifier application number: M020 DD Cream DD CREAM DERMAdoctor, Inc. 08c9a0cf-ee78-483b-e054-00144ff88e88 2025-10-16 Warnings Exact identifier application number: M020 Ciele Bronze and Protect ZINC OXIDE Ciele LLC 22003cbf-5a6d-001b-e063-6394a90aefdd 2025-10-15 Warnings Exact identifier application number: M020 Ciele Blush and Protect ZINC OXIDE Ciele 0162c891-ba2d-a78f-e063-6394a90a156c 2025-10-15 Warnings Exact identifier application number: M020 Ciele Filter and Protect TITANIUM DIOXIDE, ZINC OXIDE Ciele 0309b0ef-baca-b41d-e063-6294a90a49d7 2025-10-15 Warnings Exact identifier application number: M020 Ciele Sculpt and Protect ZINC OXIDE Ciele LLC 21ff7f78-b543-0bea-e063-6294a90aed70 2025-10-15 Warnings Exact identifier application number: M020 LATHER- DAILY DEFENSE MINERAL SPF 50 BODY SUNSCREEN ZINC OXIDE Lather, Inc. 3158a2d7-0db5-f5bf-e063-6294a90a3126 2025-10-15 Warnings Exact identifier application number: M020 LATHER- DAILY DEFENSE MINERAL SPF 50 ZINC OXIDE Lather, Inc. 81cf57b0-6072-432f-b421-7d1a708da1c4 2025-10-15 Warnings Exact identifier application number: M020 Ciele Glow and Protect ZINC OXIDE Ciele Cosmetics 27310d47-de1b-2149-e063-6394a90abe83 2025-10-15 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