Home NDC 85585-203 Tinted Mineral Sunscreen
Product NDC 85585-203
11-digit product format 855850203
Labeler code 85585
Product ID 85585-203_46161253-7b9f-afb1-e063-6394a90a64d5
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-30
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 38; 80 mg/g; mg/g
NDC exclude flag No
Listing certified through 2026-12-31
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 Tinted Mineral Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 38 mg/g TITANIUM DIOXIDE 80 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85585-203-15 Tinted Mineral Sunscreen 1.5 g in 1 PACKET CREAM 1.5 2 85585-203-50 Tinted Mineral Sunscreen 53 g in 1 BOTTLE, PUMP CREAM 53 2
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 157 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EELHOE Matte Sun Stick TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 42cfa690-15fe-e5de-e063-6394a90a8e71 2025-11-27 Warnings Exact identifier application number: M020 JAYSUING Moisturiser Sun Stick TITANIUM DIOXIDE Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. 42c307d9-aaa9-30df-e063-6294a90aa114 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral Sunscreen Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 4494bea6-ab1f-aae6-e063-6394a90a184d 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Baby Mineral Sunscreen Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44853202-6873-0bc8-e063-6394a90a05f0 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 43f43c5a-2680-f549-e063-6394a90aade3 2025-11-27 Warnings Exact identifier application number: M020 Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50 TITANIUM DIOXIDE, ZINC OXIDE THG Beauty USA LLC 44952d01-7f38-0a9c-e063-6394a90a2018 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Tropical coco ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44954d7c-2a78-3df4-e063-6294a90ab56f 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral Sunscreen Stick SPF 50 Watermelon and Coco ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 449712ab-5c23-7d50-e063-6394a90ab7fe 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Sun kissed vanilla ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44991f67-9160-ccce-e063-6394a90ada1f 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Sprayer SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 4499bcda-f0ba-878e-e063-6394a90a5fc0 2025-11-27 Warnings Exact identifier application number: M020 EcoZinc Kids Natural Mineral Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 44615ae4-8206-122d-e063-6294a90a0b2c 2025-11-27 Warnings Exact identifier application number: M020 HANCHOBIT Sunscreen TITANIUM DIOXIDE HANCHOYEANBIOTEC Co.,Ltd. 42fd5d3e-4e98-86d7-e063-6294a90a45c2 2025-11-27 Warnings Exact identifier application number: M020 HANCHOBIT Sunscreen TITANIUM DIOXIDE HANCHOYEANBIOTEC Co.,Ltd. 375b60f1-ad33-578a-e063-6294a90a1fc6 2025-11-27 Warnings Exact identifier application number: M020 EcoZinc x DSO Welders 98 percent UVC Protection Sunscreen for Welding ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 386e35de-cd13-f430-e063-6394a90acc84 2025-11-27 Warnings Exact identifier application number: M020 HANCHOBIT Matte Sun Stick TITANIUM DIOXIDE HANCHOYEANBIOTEC Co.,Ltd. 375bacf7-9372-bff7-e063-6294a90ae67c 2025-11-27 Warnings Exact identifier application number: M020 EcoZinc Natural Mineral Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 386e23ec-7618-f42c-e063-6394a90a595d 2025-11-27 Warnings Exact identifier application number: M020 KOVR Military grade sunscreen for Men ZINC OXIDE ACTIVE LIFE INC c9fbbc6e-6284-4308-89a3-98300c3a0320 2025-11-26 Warnings Exact identifier application number: M020 Alba Botanica Sensitive Mineral SPF 50 ZINC OXIDE The Hain Celestial Group, Inc. 4484b16f-f29a-60cc-e063-6294a90a2b9d 2025-11-26 Warnings Exact identifier application number: M020 Alba Botanica Sheer Mineral SPF50 ZINC OXIDE The Hain Celestial Group, Inc. 0cf9c4b9-8e85-980c-e063-6394a90a9e7e 2025-11-26 Warnings Exact identifier application number: M020 Alba Botanica Sensitive Mineral SPF 30 ZINC OXIDE The Hain Celestial Group, Inc. 44867882-d9c1-7389-e063-6294a90a7f77 2025-11-26 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 85585-203-15 85585020315 1.5 g in 1 PACKET (85585-203-15) 1.5 g 2021-03-23 Yes No Current 85585-203-50 85585020350 53 g in 1 BOTTLE, PUMP (85585-203-50) 53 g 2025-05-30 No No Current