Home NDC 85448-003-01 Ultra Sunscreen
Product NDC 85448-003
Requested package NDC 85448-003-01
11-digit product format 854480003
Labeler code 85448
Product ID 85448-003_4ed974b8-6c12-08e0-e063-6294a90a7713
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Octisalate, Titanium Dioxide
Dosage form EMULSION
Route TOPICAL
Labeler Jiangsu Senwo Medical Technology Co., Ltd.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-07
Substance OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
Active strength .09; .035; .027 g/mL; g/mL; g/mL
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 Ultra Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE .09 g/mL OCTISALATE .035 g/mL TITANIUM DIOXIDE .027 g/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup 4X49Y0596W 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 85448-003-01 Ultra Sunscreen 473 mL in 1 BOTTLE EMULSION 473 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 114 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zinc 20 mineral sunscreen face Plus body ZINC OXIDE PURE VITALITY SKIN AND BODY, INC 36985373-22dd-2232-e063-6394a90a76fb 2025-12-16 Exact identifier application number: M020 Matte Defense Mineral Sunscreen non tinted TITANIUM DIOXIDE, ZINC OXIDE PURE VITALITY SKIN AND BODY, INC 3698090a-1639-00f9-e063-6394a90a7dd1 2025-12-16 Exact identifier application number: M020 Daily Replenish mineral sunscreen ZINC OXIDE PURE VITALITY SKIN AND BODY, INC 3698d309-b9bf-e197-e063-6294a90af5a1 2025-12-16 Exact identifier application number: M020 Zinc 20 mineral sunscreen face Plus body ZINC OXIDE PURE VITALITY SKIN AND BODY, INC 3698f29e-5d80-94af-e063-6394a90a0489 2025-12-16 Exact identifier application number: M020 Tinted Mineral Primer SPF 40 TITANIUM DIOXIDE, ZINC OXIDE JOSEPHINA RAMIREZ 365cf2be-8862-3622-e063-6394a90ac4e3 2025-12-16 Exact identifier application number: M020 SANCTUARY Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CHAMPAGNE APOTHECARY LLC 365ca99c-c878-1f4b-e063-6394a90a1f53 2025-12-16 Exact identifier application number: M020 Tinted Mineral Defense SPF 40 ZINC OXIDE JOSEPHINA RAMIREZ 365d299a-5886-5597-e063-6394a90a336c 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE MILL VALLEY DERMATOLOGY, INC. 3b171a89-c757-47a1-e063-6294a90a7a64 2025-12-16 Warnings Exact identifier application number: M020 Tinted BB Cream ZINC OXIDE Eco Esthetics LLC 38f3e618-59e1-4504-e063-6394a90afa55 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE MADRE TIERRA, INC. 3f697463-d3db-7b73-e063-6394a90ac222 2025-12-16 Warnings Exact identifier application number: M020 Non-Tinted Replenishing Daily Protection ZINC OXIDE MADRE TIERRA, INC. 3f69d6f3-454b-e60a-e063-6394a90a8781 2025-12-16 Warnings Exact identifier application number: M020 Mineral Sunscreen ZINC OXIDE ISIS GONZALEZ 3f68b2ea-be23-100d-e063-6294a90a8b37 2025-12-16 Warnings Exact identifier application number: M020 Mineral Sunscreen ZINC OXIDE ISIS GONZALEZ 3f682b78-e1c9-e174-e063-6294a90a17ed 2025-12-16 Warnings Exact identifier application number: M020 Silk Screen Tinted TITANIUM DIOXIDE, ZINC OXIDE Skin Science Institute Inc 36c3793a-ccb5-1e5f-e063-6294a90ad44f 2025-12-16 Exact identifier application number: M020 Silk Screen Tinted TITANIUM DIOXIDE, ZINC OXIDE Skin Science Institute Inc 36c3a721-6be1-3f7f-e063-6394a90a522f 2025-12-16 Exact identifier application number: M020 True Tone Tinted TITANIUM DIOXIDE, ZINC OXIDE That Face PLLC 36c2bb0e-479d-89cd-e063-6294a90aa3d4 2025-12-16 Exact identifier application number: M020 True Tone Non Tinted ZINC OXIDE That Face PLLC 36c2f263-67cf-e8cf-e063-6394a90ad81f 2025-12-16 Exact identifier application number: M020 Tinted Daily Protection Sunscreen ZINC OXIDE Kemmi Lee Skin Science 37ef5a05-54d2-a8e4-e063-6394a90a8e48 2025-12-16 Exact identifier application number: M020 Aquaphor Lip Repair Stick and Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, Beiersdorf Inc d469bddf-90d4-7b1c-e053-2a95a90a1ed9 2025-12-16 Warnings Exact identifier application number: M020 Eucerin Daily Protection Face ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE Beiersdorf Inc 76403f03-aee9-4c0b-b331-f79b6953118c 2025-12-16 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 85448-003-01 85448000301 473 mL in 1 BOTTLE (85448-003-01) 473 ml 2026-04-07 No No Current