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 121 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bio H Plus Daily Defense And Revitalize ZINC OXIDE BIOHEALTH PLUS LLC 3765331e-ad4b-5661-e063-6294a90a7c20 2025-12-15 Exact identifier application number: M020 Facial Mineral Fusion TITANIUM DIOXIDE, ZINC OXIDE IT INTELLIGENT TREATMENT LLC 35944621-e6fb-cd98-e063-6294a90aa641 2025-12-15 Exact identifier application number: M020 Face Love ZINC OXIDE CLARITY SKIN CARE STUDIO, INC. 35d043a7-7269-469f-e063-6294a90a1a4d 2025-12-15 Exact identifier application number: M020 Mineral Mousse TITANIUM DIOXIDE, ZINC OXIDE CLARITY SKIN CARE STUDIO, INC. 35d00778-3857-ce8f-e063-6394a90ab375 2025-12-15 Exact identifier application number: M020 Chem-Free Sunscreen Non-Tinted Formula ZINC OXIDE IT INTELLIGENT TREATMENT LLC 3594d573-c680-62c9-e063-6294a90a4229 2025-12-15 Exact identifier application number: M020 Chem Free Sunscreen Tinted Formula ZINC OXIDE IT INTELLIGENT TREATMENT LLC 35948531-37ef-1fce-e063-6294a90ae79b 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE R. Sonia Batra, MD, Inc. 35933039-8beb-9f98-e063-6394a90a60bb 2025-12-15 Exact identifier application number: M020 Simply Protected Tinted Mineral Sunscreen ZINC OXIDE Healthy Skin & Body LLC 380416b9-180a-3904-e063-6294a90a7bee 2025-12-15 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE R. Sonia Batra, MD, Inc. 3592edca-cab0-6c44-e063-6294a90a1727 2025-12-15 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Healthy Skin & Body LLC 38046e71-f171-7e96-e063-6294a90a1f0b 2025-12-15 Exact identifier application number: M020 Barrier Plus Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Healthy Skin & Body LLC 38038beb-d0f0-ced2-e063-6294a90ac423 2025-12-15 Exact identifier application number: M020 Extreme Protection Non Tinted ZINC OXIDE BIOHEALTH PLUS LLC 3764cbeb-55f5-4a9c-e063-6394a90a863d 2025-12-15 Exact identifier application number: M020 Happy Mineral Sunscreen Primer SPF TITANIUM DIOXIDE, ZINC OXIDE ACNE CLINIC LAS VEGAS BY JUSTINA 37d9c5f2-f414-6efa-e063-6294a90a927f 2025-12-15 Exact identifier application number: M020 Comfort Mineral Mousse Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BIOHEALTH PLUS LLC 3765dd17-ffbd-bcf4-e063-6394a90a2c2b 2025-12-15 Exact identifier application number: M020 Prime And Protect Dewy ZINC OXIDE Kalon Skin Studio, LLC 3593cefe-a08f-eb88-e063-6394a90aaff6 2025-12-15 Exact identifier application number: M020 Glow ZINC OXIDE GODDESSLYNNEBODYANDSKIN 37247365-33ee-563d-e063-6394a90a249e 2025-12-15 Exact identifier application number: M020 Prime And Protect Matte TITANIUM DIOXIDE, ZINC OXIDE Kalon Skin Studio, LLC 35939630-1166-1c70-e063-6294a90aac6b 2025-12-15 Exact identifier application number: M020 Non-Tinted 20% Zinc Mineral Sunscreen ZINC OXIDE BELLA MEDICAL SKIN CARE 36d9d83b-7da5-a006-e063-6394a90a9d84 2025-12-15 Exact identifier application number: M020 Non-Tinted 20% Zinc Mineral Sunscreen ZINC OXIDE BELLA MEDICAL SKIN CARE 36da1a55-c076-cdd9-e063-6294a90ac97c 2025-12-15 Exact identifier application number: M020 Tinted Lip Balm TITANIUM DIOXIDE, ZINC OXIDE Goldberg, Howard S MD Inc 3598205d-2e87-9292-e063-6294a90a1f2a 2025-12-15 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