Home NDC 49358-571 Mineral Tinted SPF 30
Product NDC 49358-571
11-digit product format 493580571
Labeler code 49358
Product ID 49358-571_36d86ec1-c63c-d417-e063-6394a90a5f9f
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide and Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler MDSolarSciences
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-01
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 20; 170 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 49358-571-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 49358-571-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 49358-571-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 49358-571-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49358-571-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49358-571-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49358-571-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 Mineral Tinted SPF 30
Brand name suffix Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 20 mg/mL ZINC OXIDE 170 mg/mL
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49358-571-01 Mineral Tinted SPF 30Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min) 1 in 1 CARTON CREAM 1 2 49358-571-01 Mineral Tinted SPF 30Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min) 50 mL in 1 TUBE CREAM 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49358-571 MINERAL TINTED SPF 30 MINERAL TINTED SPF 30 BROAD SPECTRUM SUNSCREEN WATER RESISTANT (80 MIN) (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MDSOLARSCIENCES] 1 Current NDC, 2 package rows 20230910_adcd6881-fa25-4312-95e5-5b47102aa6b9.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 142 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Foam Weightless Sunscreen Non-Tinted Drytouch NT TITANIUM DIOXIDE, ZINC OXIDE Cutis Wellness Dermatology And Dermatopathology PLLC 335ec22c-6a9a-c4d1-e063-6394a90ac0b0 2025-12-09 Exact identifier application number: M020 Mineral Sunscreen Moisturizing Non-Tinted ZINC OXIDE Cutis Wellness Dermatology And Dermatopathology PLLC 3360a208-5f17-a74b-e063-6294a90a13e1 2025-12-09 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 323356ea-31a0-6ff0-e063-6294a90a135c 2025-12-09 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 32330376-5db0-202b-e063-6294a90add15 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Untinted ZINC OXIDE Lily Lee, MD 32354468-94a2-604b-e063-6394a90adfb5 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Tinted ZINC OXIDE Lily Lee, MD 32346536-f542-ef0f-e063-6394a90a0464 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Mineral Stick Untinted TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 3234b498-5b56-55f4-e063-6294a90a9b87 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Tinted ZINC OXIDE Lily Lee, MD 3235a696-92aa-788c-e063-6394a90a0149 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Mineral Stick Tinted TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 32351db0-884c-8fa0-e063-6294a90acba2 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Untinted ZINC OXIDE Lily Lee, MD 3235786d-7ba9-c9ab-e063-6294a90a7f2e 2025-12-09 Exact identifier application number: M020 Tinted Mineral Sunscreen 20% Zinc Oxide ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 31416d04-2d6f-7cf9-e063-6294a90a9806 2025-12-09 Warnings Exact identifier application number: M020 Matte Invisible Mineral Sunscreen Non-Tinted ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 3143968a-096e-b9ac-e063-6294a90ada0d 2025-12-09 Warnings Exact identifier application number: M020 Daily Mineral Sunscreen 20% Zinc Oxide ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 314299b1-a78b-c1bd-e063-6294a90ab43b 2025-12-09 Warnings Exact identifier application number: M020 Sheer Satin Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 3143d8b0-4af8-f52d-e063-6294a90a926b 2025-12-09 Warnings Exact identifier application number: M020 Matte Invisible Mineral Sunscreen ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 3142ed0f-f379-f240-e063-6294a90a5303 2025-12-09 Warnings Exact identifier application number: M020 Sheer Non-Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE Face Collection, L.L.C. 33d83cfb-045d-141c-e063-6394a90a2e04 2025-12-09 Exact identifier application number: M020 First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 45875865-5e9c-d652-e063-6394a90ad5fa 2025-12-09 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Maloney Plastic Surgery Skin Care, PLLC 316b7584-c782-fe9e-e063-6394a90a76fe 2025-12-09 Exact identifier application number: M020 Transparent Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE Face Collection, L.L.C. 33dbfd9b-b90f-bb32-e063-6294a90af7dc 2025-12-09 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Maloney Plastic Surgery Skin Care, PLLC 316b46ac-6dde-72d1-e063-6294a90a03da 2025-12-09 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 49358-571-01 49358057101 1 TUBE in 1 CARTON (49358-571-01) / 50 mL in 1 TUBE 1 tube 2023-07-01 No No Current