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 29 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join INNISFREE DAILY UV INVISIBLE BARRIER SUNSCREEN SERUM AVOBENZONE, HOMOSALATE, AND OCTISALATE Innisfree Corporation 524264b8-d360-1d7b-e063-6394a90ab115 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST12 KOKKINI) ZINC OXIDE Ilia, Inc. b595bcc6-a1ab-25c9-e053-2995a90a87aa 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST11.5 MORGAT) ZINC OXIDE Ilia, Inc. b97f7fe9-c070-7c11-e053-2a95a90a6a6d 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST0.5 SKYE) ZINC OXIDE Ilia, Inc. b959e3c3-ca92-ee41-e053-2a95a90a6064 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST17 MIHO) ZINC OXIDE Ilia, Inc. b595f875-b774-f847-e053-2995a90a2886 2026-05-21 Warnings Exact identifier application number: M020 LBEL FOREVER MATTE SHINE CONTROL AND 90H HYDRATION FOUNDATION SPF 15 CREME 110C OCTINOXATE, ZINC OXIDE BEL STAR S.A. 526a8e50-b1de-47e5-e063-6394a90a3a29 2026-05-21 Warnings Exact identifier application number: M020 Live Tinted Hueguard Skin Tint ZINC OXIDE Live Tinted 0ff39ab1-e8d3-cad9-e063-6394a90af0eb 2026-05-21 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Quartz 001 ZINC OXIDE Sunsolve MD Inc 26a54f00-d84d-8fe3-e063-6394a90a03e8 2026-05-21 Warnings Exact identifier application number: M020 Inde Wild ZINC OXIDE Inde Wild 01529c59-8806-6423-e063-6294a90a49e3 2026-05-21 Warnings Exact identifier application number: M020 CARDON SPF and MOISTURIZER AVOBENZONE, HOMOSALATE, OCTYL SALICYLATE Cardon, Inc 52122434-6e6f-39fc-e063-6394a90a1fd0 2026-05-21 Warnings Exact identifier application number: M020 Reactive Plus Anti-Oxidant Serum plus Broad-spectrum SPF 45 OCTINOXATE AND ZINC OXIDE Merz North America, Inc 62c822d9-c8ed-4b95-8d88-806295f5a936 2026-05-20 Warnings Exact identifier application number: M020 SkinCeuticals Future Mineral UV Defense Invisble Sunscreen Mineral Filters Broad Spectrum SPF 50 TITANIUM DIOXIDE AND ZINC OXIDE L'Oreal USA Products Inc 0b92a940-0dd4-4266-bd47-88c27def62c0 2026-05-20 Warnings Exact identifier application number: M020 Stream2Sea SPF 50 ZINC OXIDE Stream2Sea 5243f110-fe5b-946a-e063-6394a90add7e 2026-05-20 Warnings Exact identifier application number: M020 SP-FB0D-L0TNBarrierProtectionMineralSunscreen BARRIER PROTECTION MINERAL SUNSCREEN Epic Etailers, LLC (DBA: Beauty by Earth) 50786950-1c31-e467-e063-6394a90a6fc8 2026-05-20 Warnings Exact identifier application number: M020 IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 50 TITANIUM DIOXIDE AND ZINC OXIDE L'Oreal USA Products Inc. fded7dfb-ffb9-4fb0-9511-273e0e126969 2026-05-20 Warnings Exact identifier application number: M020 Freaks of Nature Peak Performance Broad Spectrum SPF 50 FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 50 THE FREAKS OF NATURE, INC. 5247187d-a14c-6468-e063-6394a90ace3e 2026-05-20 Warnings Exact identifier application number: M020 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 OCTINOXATE AND ZINC OXIDE Merz North America, Inc. e120a659-0dfc-42ca-8158-58e8a0b457e5 2026-05-20 Warnings Exact identifier application number: M020 Evereden Cooling Mineral Sunstick SPF 30 ZINC OXIDE Eden Brands Inc. 4af9e668-0d88-74ad-e063-6394a90a5243 2026-05-19 Warnings Exact identifier application number: M020 Freaks of Nature Peak Performance Broad Spectrum SPF 30 FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 30 THE FREAKS OF NATURE, INC. 522addd5-9701-3234-e063-6294a90aaa9d 2026-05-19 Warnings Exact identifier application number: M020 Freaks of Nature Peak Performance Broad Spectrum SPF 30 FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 30 THE FREAKS OF NATURE, INC. 522b4aca-fe5b-dfe2-e063-6394a90ae578 2026-05-19 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