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 180 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Wonderscreen Broad Spectrum SPF 30 ZINC OXIDE Wasatch Product Development, LLC. e895d942-e50e-1ad6-e053-2995a90a0e02 2025-10-10 Warnings Exact identifier application number: M020 Illuminating SPF 50 plus drops Broad Spectrum Sunscreen ZINC OXIDE Cosmetic Enterprise Ltd 13f40485-b98e-e804-e063-6394a90af2af 2025-10-10 Warnings Exact identifier application number: M020 Impeccable Skin Moisturizing Face Sunscreen Broad Spectrum SPF 30 ZINC OXIDE Cosmetic Enterprises LTD a84d246b-1153-85ff-e053-2995a90a270a 2025-10-10 Warnings Exact identifier application number: M020 MediChoice Moisturizing Lip Balm SPF15 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE O&M HALYARD, INC. 00327815-28f0-4198-bca7-c8ae768ff416 2025-10-09 Warnings Exact identifier application number: M020 Daybird 4-in-1 Skin Tint Serum ZINC OXIDE Resette, Inc. 19c1a934-b0f5-1068-e063-6294a90a3b1f 2025-10-09 Warnings Exact identifier application number: M020 pavise Lip Defense tinted hydrating oil (hue 604) ZINC OXIDE B.A.I. Biosciences INC. f4ebbc1d-d521-1a47-e053-2a95a90a6f84 2025-10-09 Warnings Exact identifier application number: M020 pavise Lip Defense tinted hydrating oil (hue 774) ZINC OXIDE B.A.I. Biosciences INC. f4ebd850-11a8-0d43-e053-2a95a90a2d34 2025-10-09 Warnings Exact identifier application number: M020 pavise Lip Defense tinted hydrating oil (hue 616) ZINC OXIDE B.A.I. Biosciences INC. f4eb6b20-7c26-2942-e053-2a95a90abd31 2025-10-09 Warnings Exact identifier application number: M020 Premium Moisturizing Sunscreen Broad Spectrum SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Wasatch Product Development, LLC f4346f7a-3642-05d8-e053-2a95a90a013d 2025-10-09 Warnings Exact identifier application number: M020 Premium Moisturizing Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Wasatch Product Development, LLC f4206dad-6a17-2f56-e053-2a95a90a69dc 2025-10-09 Warnings Exact identifier application number: M020 Premium Moisturizing Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Wasatch Product Development, LLC f434089c-126f-441c-e053-2995a90ab0c7 2025-10-09 Warnings Exact identifier application number: M020 BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis) ZINC OXIDE Napoleon PerdisCosmetic Pty Ltd be64bb40-b1a9-2308-e053-2a95a90a69c8 2025-10-09 Warnings Exact identifier application number: M020 Organys Open Formula Sheer ZINC OXIDE Organys Beauty 0b3ab551-cb66-cf86-e063-6394a90a7ab4 2025-10-09 Warnings Exact identifier application number: M020 Dr Lift Mineral SPF 50 TITANIUM DIOXIDE, ZINC OXIDE Spa de Soleil 40c03d65-8d09-371a-e063-6294a90a7ac6 2025-10-09 Warnings Exact identifier application number: M020 Organys Derma Made Sheer ZINC OXIDE Organys Beauty 0b39f550-bd34-509d-e063-6294a90a51d0 2025-10-09 Warnings Exact identifier application number: M020 Organys Derma Made ZINC OXIDE Organys Beauty 0b37a73b-73ca-501f-e063-6294a90a6291 2025-10-09 Warnings Exact identifier application number: M020 Organys Derma Made ZINC OXIDE Organys Beauty 09b8b8c0-4066-9cbe-e063-6394a90aca24 2025-10-09 Warnings Exact identifier application number: M020 Dr Lift Mineral SPF 30 TITANIUM DIOXIDE Spa de Soleil 40c0e0d2-2c1d-e629-e063-6394a90a5aaf 2025-10-09 Warnings Exact identifier application number: M020 Daybird Tinted Skincare (SHADE 3) ZINC OXIDE Resette, Inc dc89ab76-da32-4f6f-e053-2995a90a8bcb 2025-10-09 Warnings Exact identifier application number: M020 Daybird Tinted Skincare (SHADE 4) ZINC OXIDE Resette, Inc dc89ab0b-d53e-983f-e053-2a95a90a127f 2025-10-09 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 61354-190-01 61354019001 1 CUP in 1 CARTON (61354-190-01) / 100 mg in 1 CUP 1 cup 2025-07-18 No No Current