Home NDC 85331-203 Tinted Sunscreen
Product NDC 85331-203
11-digit product format 853310203
Labeler code 85331
Product ID 85331-203_45af23fa-cc5a-1a7e-e063-6394a90acf71
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Scottsdale Skin Boutique and Dermatology Pllc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-07-20
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 80; 38 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 Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 80 mg/g ZINC OXIDE 38 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z 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 85331-203-15 Tinted Sunscreen 15 g in 1 PACKET CREAM 15 2 85331-203-50 Tinted Sunscreen 53 g in 1 BOTTLE, PUMP CREAM 53 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85331-203 TINTED SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SCOTTSDALE SKIN BOUTIQUE AND DERMATOLOGY PLLC] 1 Current NDC, 1 package rows 20250510_34a52011-b781-75cf-e063-6394a90ae0f4.zip 85331-203 TINTED SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SCOTTSDALE SKIN BOUTIQUE AND DERMATOLOGY PLLC] 1 Current NDC, 1 package rows 20250510_34a632f5-4458-e335-e063-6394a90a9bcb.zip
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 324 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Personalized Day Moisturizer with SPF TITANIUM DIOXIDE, ZINC OXIDE Proven Skincare 3b6546ed-22ee-48e6-83cc-5cbadf567499 2023-11-10 Warnings Exact identifier application number: M020 Proven Personalized Day Moisturizer With SPF 50 ZINC OXIDE Proven Skincare ba9b3cdc-c237-7ce2-e053-2995a90ac175 2023-11-10 Warnings Exact identifier application number: M020 MIAMI BEACH BUM Save Face SPF-30 Sunscreen ZINC OXIDE MIAMI BEACH BUM 538742bc-d8f3-47d9-a85f-f2b1314f5507 2023-11-10 Warnings Exact identifier application number: M020 Tropical Sands SPF-30 Broad Spectrum Sunscreen (Coconut) TITANIUM DIOXIDE, ZINC OXIDE Elements Brands, Inc. 4935f888-cd92-61d1-e054-00144ff8d46c 2023-11-10 Warnings Exact identifier application number: M020 Coral Safe SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Elements Brands, Inc. 4925a507-863f-1088-e054-00144ff8d46c 2023-11-10 Warnings Exact identifier application number: M020 CoralSafe Broad Spectrum SPF30 TITANIUM DIOXIDE, ZINC OXIDE Elements Brands e6e00896-b7e5-41c6-a72b-08e600758cf5 2023-11-10 Warnings Exact identifier application number: M020 Coral Safe SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Elements Brands, Inc. 4925a3ad-6379-108a-e054-00144ff8d46c 2023-11-10 Warnings Exact identifier application number: M020 BELASOL Sun Cream Non-Tinted Moisturizing SPF 50 TITANIUM DIOXIDE, ZINC OXIDE EK Clothing LLC dba Belasol fb677ad0-2791-44ec-9720-951471ec009a 2023-11-09 Warnings Exact identifier application number: M020 Shaklee Youth Age Defense Mineral Moisturizer SPF 30 TITANIUM DIOXIDE Shaklee Corporation f4888fdc-09f9-43de-8c81-5a0f5e767d4e 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Eco 30 Broad Spectrum SPF 30 ZINC OXIDE Raw Elements LLC bcce6d5b-d641-4484-a4dd-06b81170f863 2023-11-09 Warnings Exact identifier application number: M020 Spit and Polish Mineral Face SPF 30 ZINC OXIDE Naturally Uncommon, LLC af86fca8-571c-0cac-e053-2a95a90ae402 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Tint 30 Broad Spectrum SPF 30 ZINC OXIDE Raw Elements LLC 801a616a-5007-4951-8bc5-b8ffe9f0bb19 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Baby Kids Broad Spectrum SPF30 ZINC OXIDE Raw Elements LLC fda8fce8-a164-45b5-b6ca-b1efce474089 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Lip Rescue 30 Broad Spectrum SPF 30 ZINC OXIDE Raw Elements LLC 74b8eac3-4bc6-430b-b4b9-eabe3280d7af 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Baby Kids Broad Spectrum SPF30 Sunscreen ZINC OXIDE Raw Elements LLC a6e5f808-65c7-4810-a15c-413111216dae 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Eco Formula 30 Broad Spectrum SPF 30 ZINC OXIDE Raw Elements LLC 1d130543-9e12-42f4-80b4-915dbe0f85d4 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Facial Moisturizer Tint Formula 30 SPF 30 Broad Spectrum ZINC OXIDE Raw Elements LLC 8aff5517-8b3d-490e-b821-973baea2d079 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Daily Moisturizer Broad Spectrum SPF30 ZINC OXIDE Raw Elements LLC 92c5f11b-5585-4479-8ee3-315c7e72574f 2023-11-09 Warnings Exact identifier application number: M020 Big Mood SPF 30 Milky Lip Balm ZINC OXIDE Everyday Group Limited c83098af-3cf9-78f6-e053-2995a90a0d01 2023-11-09 Warnings Exact identifier application number: M020 Spit and Polish Sun Smart Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Naturally Uncommon, LLC af879a05-1483-5c11-e053-2995a90af45d 2023-11-09 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 85331-203-15 85331020315 15 g in 1 PACKET (85331-203-15) 15 g 2022-07-28 Yes No Current 85331-203-50 85331020350 53 g in 1 BOTTLE, PUMP (85331-203-50) 53 g 2022-07-20 No No Current