Home NDC 85448-003 Ultra Sunscreen
Product NDC 85448-003
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 182 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vertra Pearl White Face Stick SPF 50 PADIMATE O, TITANIUM DIOXIDE Eai-jr 286, Inc b69a75e0-8724-35ae-e053-2a95a90a5f34 2025-10-07 Warnings Exact identifier application number: M020 Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige TITANIUM DIOXIDE EAI-JR 286, Inc. b9ea12e8-6ed9-d805-e053-2a95a90aa107 2025-10-07 Warnings Exact identifier application number: M020 SPF50 Sunscreen SUNSCREEN KINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD b3cde609-7d62-2ac7-e053-2a95a90a26b3 2025-10-07 Exact identifier application number: M020 Summer Face Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUMMER GELEE LLC fe256ff4-cb92-4262-8ab9-7cc912e0af22 2025-10-06 Warnings Exact identifier application number: M020 Sun Veil Broad Spectrum SPF50 ZINC OXIDE MONAT GLOBAL CORP 3ba28de7-74a2-5cde-e063-6394a90add26 2025-10-06 Warnings Exact identifier application number: M020 Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige TITANIUM DIOXIDE Toshiki Pigment Co., Ltd. b9eba15f-493a-43c9-e053-2995a90a0451 2025-10-06 Warnings Exact identifier application number: M020 Apple Lip Balm with Aloe Vera BROAD SPECTRUM SPF 15 SUNSCREEN LIP BALM Durvet, Inc. 6dcbb2cd-e690-4970-8cf1-08ca539d3602 2025-10-06 Warnings Exact identifier application number: M020 PURE SOL SPF 50 Daily Moisturizer ZINC OXIDE Brand 2022b LLC 4051506c-fc13-cd22-e063-6394a90a977e 2025-10-04 Warnings Exact identifier application number: M020 PURE SOL SPF 30 Mineral Whipped Sunscreen (Shimmer) ZINC OXIDE Brand 2022b LLC 4051ced5-85cf-6211-e063-6394a90a09fc 2025-10-04 Warnings Exact identifier application number: M020 PURE SOL SPF 30 Mineral Whipped Sunscreen ZINC OXIDE Brand 2022b LLC 4051d241-6890-2b06-e063-6294a90aa09d 2025-10-04 Warnings Exact identifier application number: M020 PURE SOL SPF 37 Tinted Moisturizer ZINC OXIDE TITANIUM DIOXIDE Brand 2022b LLC 4052c4e4-2105-80c0-e063-6294a90af41d 2025-10-04 Warnings Exact identifier application number: M020 PLAY Antioxidant Body Mist SPF 50 - Vanilla Orchid AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop LLC 3f7a9722-d211-e861-e063-6294a90a6cdc 2025-10-02 Warnings Exact identifier application number: M020 Kids Mineral Sunscreen SPF50 SUNSCREEN Hello Bello 01cc554b-9241-d891-e063-6394a90a8450 2025-10-02 Warnings Exact identifier application number: M020 HydroGlow Daily Sunscreen BROAD SPECTRUM SPF 50 UVA and UVB SUNSCREEN SPF 50 IHerb, LLC 3cab1598-5ef3-df73-e063-6394a90ab1e2 2025-10-01 Warnings Exact identifier application number: M020 Moisturizing Rich Sunscreen SPF 30 ZINC OXIDE Good Molecules, LLC 36c3ba26-ca25-7498-e063-6294a90a47fc 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Broad Spectrum SPF 30 Shade 1 ZINC OXIDE Dime Beauty Co, LLC 07104cbf-0446-a053-e063-6394a90ab41f 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Tinted Broad Spectrum SPF 30 Shade 3 ZINC OXIDE Dime Beauty Co, LLC 07503a1f-d530-e3bb-e063-6294a90a8ae3 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Broad Spectrum SPF 30 ZINC OXIDE Dime Beauty Co, LLC e38deed3-e1e2-0b1d-e053-2a95a90a547f 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Tinted Broad Spectrum SPF 30 ZINC OXIDE Dime Beauty Co, LLC f2a59fa4-f19c-a15f-e053-2a95a90a6ace 2025-10-01 Warnings Exact identifier application number: M020 Bronzing Blendrops Broad Spectrum SPF 46 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 414b88ca-a3df-5e42-e063-6294a90a69ba 2025-10-01 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