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 28 of 361 · 7,213 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ILIA SUPER SERUM SKIN TINT (ST6 ORA) ZINC OXIDE Ilia, Inc. b59537d4-e1d8-53e4-e053-2995a90a2ce3 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST16 PAVONES) ZINC OXIDE Ilia, Inc. b595f1e9-36f7-615d-e053-2a95a90abb1c 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST2.5 SOMBRIO) ZINC OXIDE Ilia, Inc. b97dc2ac-dd6d-403d-e053-2995a90a0d9c 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST14 DOMINICA) ZINC OXIDE Ilia, Inc. b595db16-7969-726f-e053-2995a90ab783 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST11 MATIRA) ZINC OXIDE Ilia, Inc. b595b5f0-dd3d-79ef-e053-2a95a90ad9fb 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST10 PORTO FERRO) ZINC OXIDE Ilia, Inc. b595a378-3285-bea2-e053-2995a90aedbf 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST15 PORTO COVO) ZINC OXIDE Ilia, Inc. b595db16-796c-726f-e053-2995a90ab783 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST2 TULUM) ZINC OXIDE Ilia, Inc. b5939cc9-4eab-5f73-e053-2995a90a7a7b 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST8 SHELA) ZINC OXIDE Ilia, Inc. b5956413-af6b-11bd-e053-2a95a90a9047 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST9 PALOMA) ZINC OXIDE Ilia, Inc. b5959358-0d93-aa37-e053-2995a90acdae 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST1 RENDEZVOUS) ZINC OXIDE Ilia, Inc. b592225c-904e-350a-e053-2a95a90adc2b 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST7 DIAZ) ZINC OXIDE Ilia, Inc. b5954732-66d7-53db-e053-2995a90a2a3b 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST4 FORMOSA) ZINC OXIDE Ilia, Inc. b594d426-a79e-19e9-e053-2995a90aa665 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST3 BALOS) ZINC OXIDE Ilia, Inc. b594bc81-d164-bda7-e053-2995a90a69ad 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST18 MALI) ZINC OXIDE Ilia, Inc. b59608e6-a407-75dc-e053-2995a90a25cf 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST19 LOVINA) ZINC OXIDE Ilia, Inc. b9805c9c-0513-2386-e053-2995a90a2185 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST5 BOM BOM) ZINC OXIDE Ilia, Inc. b594f910-f1bc-2bcf-e053-2995a90aebee 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST17.5 PERISSA) ZINC OXIDE Ilia, Inc. b9805059-583d-e3da-e053-2a95a90a4f65 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST14.5 HONOPU) ZINC OXIDE Ilia, Inc. b9803596-c090-463f-e053-2a95a90a0234 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST6.5 KAI) ZINC OXIDE Ilia, Inc. b97f5589-069d-7e93-e053-2a95a90a19a9 2026-05-21 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