Home NDC 54031-020 Max Mineral
Product NDC 54031-020
11-digit product format 540310020
Labeler code 54031
Product ID 54031-020_0a2095ac-5703-39ba-e063-6294a90aa1c9
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Peter Thomas Roth Labs, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-02-15
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 9.271756; .9276575 g/48.19g; g/48.19g
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 Max Mineral
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 9.271756 g/48.19g TITANIUM DIOXIDE .9276575 g/48.19g
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54031-020-01 Max Mineral 48.19 g in 1 TUBE CREAM 48.19 3 54031-020-02 Max Mineral 48.19 g in 1 CARTON CREAM 48.19 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54031-020 MAX MINERAL (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PETER THOMAS ROTH LABS, LLC] 3 Current NDC, 2 package rows 20231115_0980992c-6488-2fa1-e063-6294a90a41ea.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 129 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Canopy Untinted ZINC OXIDE BORREGO SPRINGS SKINCARE LLC 35824cd5-0036-7886-e063-6394a90ae678 2025-12-12 Exact identifier application number: M020 Canopy SPF 40 Tinted ZINC OXIDE BORREGO SPRINGS SKINCARE LLC 358319c5-ae35-cb3b-e063-6394a90ad77f 2025-12-12 Exact identifier application number: M020 Non-Tinted Matte Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin Philosophy by Kelly 3581ab49-ef55-3743-e063-6394a90a3bd5 2025-12-12 Exact identifier application number: M020 Matte Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin Philosophy by Kelly 3581cf33-3520-42f7-e063-6394a90a6f93 2025-12-12 Exact identifier application number: M020 Mineral Sunscreen For Face and Body ZINC OXIDE Skin Philosophy by Kelly 358248e6-16cf-6f9b-e063-6394a90a55d7 2025-12-12 Exact identifier application number: M020 Replenishing Mineral Sunscreen ZINC OXIDE Skin Philosophy by Kelly 35828e76-66db-49de-e063-6294a90a2b99 2025-12-12 Exact identifier application number: M020 Matte Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin Philosophy by Kelly 3592b2c7-295a-7c60-e063-6394a90a387b 2025-12-12 Exact identifier application number: M020 Mineral Sunscreen For Face and Body ZINC OXIDE Skin Philosophy by Kelly 3592fd5f-13d1-9aec-e063-6394a90abd67 2025-12-12 Exact identifier application number: M020 Replenishing Mineral Sunscreen ZINC OXIDE Skin Philosophy by Kelly 359371f2-2407-e1a1-e063-6294a90a2165 2025-12-12 Exact identifier application number: M020 Non Tinted Sheer Mineral Zinc Sunscreen ZINC OXIDE SKIN THERAPY PLLC 397fc3c9-9d30-adcf-e063-6394a90ac761 2025-12-12 Exact identifier application number: M020 Non Tinted Sheer Mineral Zinc Sunscreen ZINC OXIDE SKIN THERAPY PLLC 39800bf1-e01a-e1c8-e063-6294a90a53bf 2025-12-12 Exact identifier application number: M020 Tinted Sheer Mineral Zinc Sunscreen ZINC OXIDE SKIN THERAPY PLLC 397130ea-dfad-ecd3-e063-6394a90a7da4 2025-12-12 Exact identifier application number: M020 Tinted Sheer Mineral Zinc Sunscreen ZINC OXIDE SKIN THERAPY PLLC 39716532-a699-63b7-e063-6294a90aa0f0 2025-12-12 Exact identifier application number: M020 Sun Elegant Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE SKIN BY NESRIN 3580ae10-1867-cb68-e063-6394a90a72df 2025-12-12 Exact identifier application number: M020 Simply Zinc Mineral Sunscreen Tinted ZINC OXIDE SKIN BY NESRIN 3580da4f-116d-8108-e063-6294a90a7bf4 2025-12-12 Exact identifier application number: M020 PROTECTOR SOLAR NON-TINTED SPF SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE The Beez Kneez Skin Care & Acne Clinic LLC 358195c0-6d28-1ffe-e063-6394a90a6027 2025-12-12 Exact identifier application number: M020 PROTECTOR SOLAR TINTED SPF SUNSCREEN ZINC OXIDE The Beez Kneez Skin Care & Acne Clinic LLC 3581d973-ac0b-7d2e-e063-6294a90ae2b3 2025-12-12 Exact identifier application number: M020 Matte Velvet Tint TITANIUM DIOXIDE, ZINC OXIDE Brent Loftis, D.O., Inc., A California Medical Corporation 3583f860-664b-2658-e063-6394a90a3857 2025-12-12 Exact identifier application number: M020 Satin Tint ZINC OXIDE Brent Loftis, D.O., Inc., A California Medical Corporation 35920108-7f8a-27d4-e063-6294a90a0ef6 2025-12-12 Exact identifier application number: M020 SPF Lip TITANIUM DIOXIDE, ZINC OXIDE Brent Loftis, D.O., Inc., A California Medical Corporation 359297cd-10e2-6ddd-e063-6394a90a4aa0 2025-12-12 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 54031-020-01 54031002001 48.19 g in 1 TUBE (54031-020-01) 48.19 g 2021-02-15 No No Current 54031-020-02 54031002002 48.19 g in 1 CARTON (54031-020-02) 48.19 g 2021-02-15 No No Current