Home NDC 49358-583 Mineral Moisture Defense SPF 50
Product NDC 49358-583
11-digit product format 493580583
Labeler code 49358
Product ID 49358-583_36d86ec1-c64d-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 49358-583-01 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 49358-583-01 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 49358-583-01 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 49358-583-01 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 49358-583-01 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 49358-583-01 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 49358-583-01 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 Moisture Defense SPF 50
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49358-583-01 Mineral Moisture Defense SPF 50 1 in 1 CARTON CREAM 1 2 49358-583-01 Mineral Moisture Defense SPF 50 100 mL in 1 TUBE CREAM 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49358-583 MINERAL MOISTURE DEFENSE SPF 50 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MDSOLARSCIENCES] 1 Current NDC, 2 package rows 20230922_05ad73f3-a4e8-4f78-8212-3e8e3bda988c.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 143 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Replenish ZINC OXIDE Maloney Plastic Surgery Skin Care, PLLC 316c43fb-0c15-87d4-e063-6294a90a0a63 2025-12-09 Exact identifier application number: M020 BIOJUVE Microbiome-Safe Sheer Finish SPF 50 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Crown Laboratories ece7565b-f3e5-3386-e053-2a95a90a5802 2025-12-09 Warnings Exact identifier application number: M020 Hydraboost Lip Treatment AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Bluemercury 2cf30083-8723-23f6-e063-6394a90a55de 2025-12-09 Warnings Exact identifier application number: M020 Florida Babe Sport Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tichy Anesthesia PA 31e4756d-8604-6e75-e063-6294a90aebe1 2025-12-09 Exact identifier application number: M020 Florida Babe Sport Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tichy Anesthesia PA 31e4d9ae-f532-f9f5-e063-6294a90a8d39 2025-12-09 Exact identifier application number: M020 Arbonne FunSun Mineral Sunscreen Broad Spectrum SPF 30 ZINC OXIDE Arbonne International, LLC 91bcd120-28e5-4f44-9522-550c1dbcd82c 2025-12-09 Warnings Exact identifier application number: M020 Florida Babe Active Tinted 20percent Zinc Oxide Mineral Sunscreen ZINC OXIDE Tichy Anesthesia PA 31e509f2-dcb6-5ae0-e063-6394a90a70c1 2025-12-09 Exact identifier application number: M020 Florida Babe Active Non-Tinted 20percent Zinc Oxide Mineral Sunscreen ZINC OXIDE Tichy Anesthesia PA 31e57817-b8c4-8178-e063-6294a90a0149 2025-12-09 Exact identifier application number: M020 Florida Babe Everyday Tinted Replenishing Daily Protection ZINC OXIDE Tichy Anesthesia PA 3231f1fe-51b3-b2e7-e063-6394a90a2758 2025-12-09 Exact identifier application number: M020 Florida Babe Everyday Tinted Replenishing Daily Protection ZINC OXIDE Tichy Anesthesia PA 31e63876-3e39-adc6-e063-6394a90ab146 2025-12-09 Exact identifier application number: M020 Florida Babe SPORT Mineral Sunscreen Stick Tinted TITANIUM DIOXIDE, ZINC OXIDE Tichy Anesthesia PA 31f5bbe4-5f6e-3bef-e063-6294a90a2646 2025-12-09 Exact identifier application number: M020 Florida Babe SPORT Mineral Sunscreen Stick Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE Tichy Anesthesia PA 31f54a79-70b7-def5-e063-6294a90a709b 2025-12-09 Exact identifier application number: M020 Florida Babe Sport Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tichy Anesthesia PA 3231b71c-4d27-e5e2-e063-6294a90a031b 2025-12-09 Exact identifier application number: M020 Arbonne Soft Focus Veil Broad Spectrum SPF 30 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Arbonne International, LLC 3c9b605b-5a16-4f89-a956-8c4c62de72d3 2025-12-09 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE THE AESTHETICS ACADEMY, LLC 364b9560-f7a1-ed8f-e063-6294a90a2c41 2025-12-09 Exact identifier application number: M020 Sunshield Moisturizing Sunscreen and Antioxidant ZINC OXIDE Oculofacial Surgery andCosmetic Laser Institute, LLC. 32c247fc-d4da-e03d-e063-6394a90a72b0 2025-12-09 Exact identifier application number: M020 SCALP SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE FOLICULE LLC 387b10e1-5443-7b7a-e063-6394a90a2c7a 2025-12-09 Exact identifier application number: M020 Sunshield Moisturizing Sunscreen and Antioxidant ZINC OXIDE Oculofacial Surgery andCosmetic Laser Institute, LLC. 32c3936e-4089-edd0-e063-6294a90ad3f8 2025-12-09 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE THE AESTHETICS ACADEMY, LLC 364cf1f7-1f87-51f7-e063-6294a90a789c 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 49358-583-01 49358058301 1 TUBE in 1 CARTON (49358-583-01) / 100 mL in 1 TUBE 1 tube 2023-07-01 No No Current