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 297 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RMS SUNCOVERUP SUPER TINT SPF 50 MAHOGANY ZINC OXIDE Rms organics LLC 1a1aebea-ed0c-ac92-e063-6294a90aeae6 2024-06-04 Warnings Exact identifier application number: M020 Brush On Block SPF 30 Mineral Powder Translucent Zinc Only ZINC OXIDE SPF Ventures, LLC 1a1bf910-f1bc-bd75-e063-6294a90a663f 2024-06-04 Warnings Exact identifier application number: M020 PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreen TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD 0b62062d-b77e-4e6c-b3ab-b35ab24db7cb 2024-06-04 Warnings Exact identifier application number: M020 Protectif Deep Tint ZINC OXIDE AND TITANIUM DIOXIDE Derma Research Group Inc. 19b19023-1340-6609-e063-6394a90a6eaf 2024-05-30 Warnings Exact identifier application number: M020 EltaMD UV Sport SPF50 ZINC OXIDE, OCTINOXATE AND OCTISALATE SUNSCREEN CP Skin Health Group, Inc. dffc3fde-5b6e-4a62-8289-9733be43455b 2024-05-30 Warnings Exact identifier application number: M020 Vacation by Vacation Scent and Shimmer Duo AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Vacation Inc. aef8388f-84bb-4e2b-8ae2-aa64f415a632 2024-05-28 Warnings Exact identifier application number: M020 SPF50 Sunscreen Cariposa ZINC OXIDE Talent Brands Company LLC 1938fa13-875a-140e-e063-6294a90a5514 2024-05-24 Warnings Exact identifier application number: M020 Derma E Vitamin C Weightless Moisturizer SPF 45 ZINC OXIDE derma e a3b404a6-e4b1-4c08-a8ef-77446dd2e411 2024-05-24 Warnings Exact identifier application number: M020 COOLA Classic Liplux Lip Balm SPF 30 Original AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC eeb420f0-c92f-0d96-e053-2a95a90afe36 2024-05-22 Warnings Exact identifier application number: M020 COOLA Mineral Liplux Lip Balm SPF 30 Nude Beach TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC ee2842c3-65e0-3904-e053-2a95a90aabff 2024-05-22 Warnings Exact identifier application number: M020 COOLA Mineral Liplux Lip Balm SPF 30 Firecracker TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC ee026a1c-885b-256f-e053-2a95a90af564 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic SPF 50 Mineral Sunscreen Vanilla Coco TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC ec96dee8-85e8-3147-e053-2995a90aaf53 2024-05-22 Warnings Exact identifier application number: M020 COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Bronze Goddess TITANIUM DIOXIDE COOLA, LLC eeb406c6-a543-379a-e053-2995a90a4998 2024-05-22 Warnings Exact identifier application number: M020 COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Fresh Rose TITANIUM DIOXIDE COOLA, LLC ee01642f-478e-b307-e053-2a95a90a7d81 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic SPF 30 Mineral Sunscreen Coco Mango ZINC OXIDE COOLA, LLC eca9ae89-19dc-516d-e053-2995a90a4698 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic Mineral Matte Untinted Face SPF 30 TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC ecabcc89-fb09-41a9-e053-2995a90a8b31 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic Mineral Matte Tinted Face SPF 30 TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC ee018c21-dca7-28aa-e053-2a95a90a3bdb 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic SPF 30 Mineral Sunscreen Citrus Cooler ZINC OXIDE COOLA, LLC ecaad342-1873-60bc-e053-2995a90a5952 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic Mineral Shimmer SPF 30 Golden Daze TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC eeb70034-0f8d-a46d-e053-2a95a90a8130 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic Mineral Shimmer SPF 30 Diamond Dust TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC eec83ecb-d0ab-7857-e053-2995a90a40ed 2024-05-22 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