Home NDC 61354-190 Powder
Product NDC 61354-190
11-digit product format 613540190
Labeler code 61354
Product ID 61354-190_4d3a0eae-1e8c-3460-e063-6394a90a8c81
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 2025-07-18
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 61354-190-01 Powder 1 in 1 CARTON POWDER 1 1 61354-190-01 Powder 100 mg in 1 CUP POWDER 100 1
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 127 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mineral Sunscreen Stick SPF 50 Fragrance-Free ZINC OXIDE COOLA LLC ee8706b0-ad42-403a-be7c-b660f040a244 2025-12-14 Warnings Exact identifier application number: M020 COOLA CLASSIC SUNSCREEN FRAGRANCE FREE AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE COOLA, LLC cfc21b1a-4a26-1573-e053-2995a90a2d50 2025-12-14 Warnings Exact identifier application number: M020 Kopari Sunglaze Sheer Body Mist Sunscreen SPF42 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kopari Beauty 7c96b799-e24d-473f-8f0a-3fad83d5ed48 2025-12-14 Warnings Exact identifier application number: M020 WOODSLEEP Sunscreen Balm TITANIUM DIOXIDE Shantou Woodsleep Biotechnology Co., Ltd. 45cfc7ed-34a6-1f45-e063-6394a90a902b 2025-12-13 Warnings Exact identifier application number: M020 Universkin by Alma Daily Mineral Serum Broad Spectrum SPF50 ZINC OXIDE 24% UNIVERSKIN 45d242de-cbd8-e7ea-e063-6394a90aaebf 2025-12-13 Warnings Exact identifier application number: M020 Mineral Sunscreen ZINC OXIDE SPF 50 ALAINA HEALTHCARE PRIVATE LIMITED b7847d4f-2517-4b58-8e31-676c9d6e484d 2025-12-12 Warnings Exact identifier application number: M020 Lip Protecting TITANIUM DIOXIDE, ZINC OXIDE JOHANNA'S SKIN CARE 3544b8f2-2651-4c01-e063-6394a90ae53d 2025-12-12 Exact identifier application number: M020 Tinted SPF40 TITANIUM DIOXIDE, ZINC OXIDE JOHANNA'S SKIN CARE 3544faa1-ebdf-5dbd-e063-6394a90a7631 2025-12-12 Exact identifier application number: M020 Replenishing Daily Protection Tinted ZINC OXIDE SOLUTIONS SKIN CARE LLC 40323dfa-29e4-1464-e063-6294a90aa65c 2025-12-12 Warnings Exact identifier application number: M020 Zinc 20Percent SPF 40 ZINC OXIDE JOHANNA'S SKIN CARE 3545ed3e-b42f-d29d-e063-6394a90a8efe 2025-12-12 Exact identifier application number: M020 Replenishing Daily Protection Non-Tinted ZINC OXIDE SOLUTIONS SKIN CARE LLC 40332cf3-e4e5-0c00-e063-6394a90a683d 2025-12-12 Warnings Exact identifier application number: M020 Replenishing Daily Protection Non-Tinted ZINC OXIDE SOLUTIONS SKIN CARE LLC 4032913b-4bc3-6920-e063-6294a90a6e2d 2025-12-12 Warnings Exact identifier application number: M020 Replenishing Daily Protection Tinted ZINC OXIDE SOLUTIONS SKIN CARE LLC 4032f0b0-c083-d227-e063-6394a90a3068 2025-12-12 Warnings Exact identifier application number: M020 Everyday Mineral Sunscreen ZINC OXIDE MYRENE DULAY-MARTINEZ 396d952b-22ff-567f-e063-6394a90a8c68 2025-12-12 Exact identifier application number: M020 Everyday Mineral Sunscreen ZINC OXIDE MYRENE DULAY-MARTINEZ 396dfc9c-b6c0-5892-e063-6394a90a110c 2025-12-12 Exact identifier application number: M020 KawaKids KawaSun - Premium Mineral Sunscreen SPF 50 ZINC OXIDE LCA COSMETICS LLC 1f41f64b-d707-08e2-e063-6294a90aa924 2025-12-12 Warnings Exact identifier application number: M020 KawaKids KawaSun - Premium On-The-Go Mineral Sunscreen SPF 50 ZINC OXIDE LCA COSMETICS LLC 1f4341f7-b499-3b73-e063-6394a90a75b8 2025-12-12 Warnings Exact identifier application number: M020 Advanced Mineral Sunscreen ZINC OXIDE Charisma Skin 351f7f72-c426-e42f-e063-6294a90a4b3a 2025-12-12 Exact identifier application number: M020 Advanced Mineral Sunscreen ZINC OXIDE Charisma Skin 351f06f3-9deb-4c1a-e063-6394a90ad766 2025-12-12 Exact identifier application number: M020 Daily Mineral Protection ZINC OXIDE Charisma Skin 352d72f6-06b9-6fdc-e063-6294a90ab448 2025-12-12 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 61354-190-01 61354019001 1 CUP in 1 CARTON (61354-190-01) / 100 mg in 1 CUP 1 cup 2025-07-18 No No Current