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 315 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SERIOUS SKINCARE SERIOUS C3 PLASMA BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30 AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE Flageoli Limited 4d11cc46-3942-1561-e054-00144ff8d46c 2023-12-12 Warnings Exact identifier application number: M020 ACTIVE ARGAN 365 SPF 30 BROAD SPECTRUM ACTIVATED ARGAN COMPLEX ZINC OXIDE SIBORG LLC 9c4897f8-8fcb-4a0f-b42e-f582e2934f02 2023-12-12 Warnings Exact identifier application number: M020 Byoma Moisturizing Gel Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE ENGLEWOOD LAB, INC. f63fe60f-9863-1dfb-e053-2a95a90a90a5 2023-12-12 Warnings Exact identifier application number: M020 MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant 80 Min TITANIUM DIOXIDE, ZINC OXIDE ENGLEWOOD LAB, INC. 5742da4b-6713-4de9-8ab8-b2bf2983371a 2023-12-12 Warnings Exact identifier application number: M020 restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea Complex ZINC OXIDE RESTORSEA INC 80ed7b28-16e0-4c9a-8e36-9d32ca3ddb9a 2023-12-12 Warnings Exact identifier application number: M020 ReVive Fermitif Neck Renewal SPF 15 AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE Gurwitch Products, LLC de54d4ff-f9b4-4a12-95ea-fc2b61bee1c3 2023-12-12 Exact identifier application number: M020 Laura Mercier Flawless Skin Daily Face Shield SPF 40 OCTINOXATE, TITANIUM DIOXIDE Gurwitch Products, LLC f86729cd-682f-47b2-9bfa-1113721bfec0 2023-12-12 Warnings Exact identifier application number: M020 Boscia BB SPF 27 PA TITANIUM DIOXIDE Boscia LLC 5dc86c0b-c340-4643-a174-a6b4c0826ca9 2023-12-12 Warnings Exact identifier application number: M020 Dr.Denese SPF 30 Defense Day ZINC OXIDE, OCTINOXATE SkinScience Labs, Inc 511dd97b-0f83-4ce9-8bfd-fa385f0dc8aa 2023-12-12 Warnings Exact identifier application number: M020 Boscia Daily Hydration SPF 15 Broad Spectrum For Normal To Oily Skin AVOBENZONE, OCTINOXATE Boscia LLC 0c987cb9-7049-44b9-9935-647b0411a734 2023-12-12 Warnings Exact identifier application number: M020 Boscia BB Broad Spectrum SPF 27 PA Self Adjusting Shade TITANIUM DIOXIDE, ZINC OXIDE Boscia LLC 82a23aab-404f-46bb-afaa-8ba9b9bdbefd 2023-12-12 Warnings Exact identifier application number: M020 Boscia Restorative Day Moisture Broad Spectrum SPF 15 For Dry Skin AVOBENZONE, OCTINOXATE Boscia LLC 657b04c6-d15b-470b-92e6-e59ed7e8b116 2023-12-12 Warnings Exact identifier application number: M020 Cellular Laboratories De-Aging Sunscreen Broad Spectrum SPF 50 Plus HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE Market America c1898e00-05f1-4e28-9fa8-8cda1b178595 2023-12-12 Warnings Exact identifier application number: M020 Boscia BB BRONZE Broad Spectrum SPF 27 PA Self-Adjusting Shade TITANIUM DIOXIDE, ZINC OXIDE Boscia LLC 5f5fb9f5-00be-420a-b19a-b753c45f9a88 2023-12-12 Warnings Exact identifier application number: M020 Boscia Self-Defense Vital Antioxidant Moisture Broad Spectrum SPF 30 AVOBENZONE, OCTINOXATE Boscia LLC 7d948951-598a-4a38-94a2-d357ee7f4d1e 2023-12-12 Warnings Exact identifier application number: M020 Restorative Day Moisture SPF 15 OCTINOXATE, AVOBENZONE Boscia LLC 01f17133-7f29-4f8e-a52c-c4466e4abefc 2023-12-12 Warnings Exact identifier application number: M020 3LAB Aqua BB SPF 40 BROAD SPECTRUM 03 TITANIUM DIOXIDE 3LAB, Inc. 8a42a9d8-b9c6-45fb-8264-15f36e2765f0 2023-12-12 Warnings Exact identifier application number: M020 3LAB Hydra Day SPF 20 Broad Spectrum Water-Based Sunscreen OCTINOXATE, OCTISALATE, AVOBENZONE 3LAB, Inc d539b851-c4b2-40a2-9562-e3a95a86b744 2023-12-12 Warnings Exact identifier application number: M020 3LAB PERFECT Lite Sunscreen SPF 30 Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE 3LAB, Inc 3052af3f-8923-47bc-be6e-17396275363a 2023-12-12 Warnings Exact identifier application number: M020 Isa SunGuard SPF 30 ZINC OXIDE, TITANIUM DIOXIDE Isagenix International, LLC abe1e345-6ea2-43b3-8613-b5b5e04c87b7 2023-12-12 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