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 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 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 185 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PUR 4-in-1 Skin Tint DG6 ZINC OXIDE PUR Minerals 3f8e97a7-2023-ba9c-e063-6294a90ac9c9 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint TN7 ZINC OXIDE PUR Minerals 3f0717c7-f43f-e3b1-e063-6394a90a74dd 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint TN2 ZINC OXIDE PUR Minerals 3f06ed2f-f43f-53d4-e063-6294a90af0dd 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint MN4 ZINC OXIDE PUR Minerals 3f06f618-f7b2-53d0-e063-6294a90a829c 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint MN3 ZINC OXIDE PUR Minerals 3f06df49-5ed2-44ca-e063-6294a90a1fda 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint LN2 ZINC OXIDE PUR Minerals 3f069dfe-289d-8d3b-e063-6394a90a0496 2025-09-24 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint LG3 ZINC OXIDE PUR Minerals 3f06ec3e-fc15-9f7b-e063-6394a90a0733 2025-09-24 Warnings Exact identifier application number: M020 Volition Prismatic Luminizing Shield ZINC OXIDE Volition 1a633c24-b9d9-4732-e063-6294a90af4c0 2025-09-24 Warnings Exact identifier application number: M020 Alleyoop Sunsational Broad Spectrum ZINC OXIDE NewAlley Innovations Inc 248419c4-8044-402c-e063-6394a90a00f8 2025-09-24 Warnings Exact identifier application number: M020 Aloe Up SPF 30 coco-mango mist AVOBENZONE 3.0%, HOMOSALATE 7.5%, OCTISALATE 5.0% Aloe Up f7b2d4a2-3a0d-4239-b7e5-8de2f6ac2e92 2025-09-24 Warnings Exact identifier application number: M020 pavise Dynamic Age Defense ZINC OXIDE B.A.I BIOSCIENCES, INC f4e9f95c-6b1e-d5f7-e053-2a95a90a93ce 2025-09-24 Warnings Exact identifier application number: M020 Aloe Up SPF 50 coco-mango mist AVOBENZONE 3.0%, HOMOSALATE 10.0%, OCTISALATE 5.0% Aloe Up d535b711-c54e-4447-9907-ca9d829d1319 2025-09-24 Warnings Exact identifier application number: M020 ESPOIR WATER SPLASH SUN SERUM HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE ESPOIR Corporation 1c4e7ba2-05e8-f949-e063-6394a90a699d 2025-09-23 Warnings Exact identifier application number: M020 Banana Boat ZINC OXIDE Edgewell Personal Care Brands LLC 1d11c3d0-5f4e-0ed0-e063-6294a90abc75 2025-09-23 Warnings Exact identifier application number: M020 Dewscreen Daily Hydrator and Primer SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop LLC 3f7c84e3-0e4f-b7e9-e063-6294a90a1295 2025-09-23 Warnings Exact identifier application number: M020 Sun Bum Daily Gel Gel Sunscreen Moisturizer Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 15d8574d-94bb-4842-e063-6394a90a15e6 2025-09-23 Warnings Exact identifier application number: M020 Sun Bum Daily Body AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 15da0cb1-e695-cec3-e063-6394a90a1afa 2025-09-23 Warnings Exact identifier application number: M020 Sun Bum Daily Face Liquid Sunscreen Moisturizer Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 15daac41-54b6-096d-e063-6294a90a0736 2025-09-23 Warnings Exact identifier application number: M020 Mtn. Bum by Sun Bum and Mcfetridge Mineral Sunscreen Face Stick SPF 50 ZINC OXIDE Sun Bum, LLC 3f8101b1-297d-2ad8-e063-6294a90a9cff 2025-09-23 Warnings Exact identifier application number: M020 Sun Bum Daily Glow Tinted Sunscreen Moisturizer Broad Spectrum SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 20c48752-3ad9-5993-e063-6294a90ae1b0 2025-09-23 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