Home NDC 49358-570 Mineral Creme SPF 50
Product NDC 49358-570
11-digit product format 493580570
Labeler code 49358
Product ID 49358-570_36d85f1d-3e7b-cf54-e063-6394a90af1ba
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 · 21 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 49358-570-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 49358-570-02 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 49358-570-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 49358-570-02 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 49358-570-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 49358-570-02 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 49358-570-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 49358-570-02 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 49358-570-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49358-570-02 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 49358-570-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49358-570-02 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 49358-570-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49358-570-02 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 Creme SPF 50
Brand name suffix Mineral Creme SPF 50 Broad Spectrum UVA-UVB 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 49358-570-01 Mineral Creme SPF 50Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min) 50 mL in 1 TUBE CREAM 50 2 49358-570-01 Mineral Creme SPF 50Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min) 1 in 1 CARTON CREAM 1 2 49358-570-02 Mineral Creme SPF 50Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min) 100 mL in 1 TUBE CREAM 100 2 49358-570-02 Mineral Creme SPF 50Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min) 1 in 1 CARTON CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49358-570 MINERAL CREME SPF 50 MINERAL CREME SPF 50 BROAD SPECTRUM UVA-UVB SUNSCREEN WATER RESISTANT (80 MIN) (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MDSOLARSCIENCES] 1 Current NDC, 4 package rows 20230910_f8e178d6-058c-462a-8e59-6721f28ad040.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 178 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30 ZINC OXIDE Babo Botanicals, Inc. 08f0436b-85b6-5099-e063-6294a90a4c2e 2025-10-09 Warnings Exact identifier application number: M020 Mist Me SPF-40 ZINC OXIDE Cove Suncare LLC b7f09089-54a4-4f60-b632-e3f4321313ec 2025-10-09 Warnings Exact identifier application number: M020 Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Allergan, Inc. 29817fdc-f14c-4013-a8ed-4367f3b2867c 2025-10-09 Warnings Exact identifier application number: M020 Skinny Dip SPF-50 ZINC OXIDE Cove Suncare LLC 7bef2966-9351-4ea6-aeed-0d568376d86b 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Broad Spectrum SPF 60 Plus AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 0f0ba2e9-126f-13c0-e063-6394a90aa6a4 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 08997bd4-d6b9-fffc-e063-6294a90a77ae 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE Kenvue Brands LLC 75f81b2d-cabc-443f-b4b5-76bd2321826b 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Sunscreen Broad Spectrum SPF 60 Plus AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 1390f863-709e-412b-9a25-b65217844e44 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC ccc2e40b-5301-4055-8a89-47366687cfb7 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 0f0dd2e4-3dda-c872-e063-6294a90a20a3 2025-10-08 Warnings Exact identifier application number: M020 ScalpHair MistSunscreen SPF30 COOLA SCALPHAIR MIST ORGANIC SUNSCREEN SPF30 COOLA LLC c7d2098f-6fdf-68e5-e053-2a95a90a1898 2025-10-08 Warnings Exact identifier application number: M020 Block Party SPF-50 ZINC OXIDE Cove Suncare LLC 24ffb6ec-d922-40c0-b325-c15f8433027a 2025-10-08 Warnings Exact identifier application number: M020 Sun Kids mineral BLUEBERRY SUNSCREEN BROAD SPECTRUM SPF 50 ZINC OXIDE The Natural SKN Company 40945805-6f2e-74a1-e063-6394a90a04a3 2025-10-07 Warnings Exact identifier application number: M020 ProtecTINT 10N HOMOSALATE, OCTISALATE, ZINC OXIDE Supergoop, LLC 0801287f-0df5-4303-e063-6394a90a503b 2025-10-07 Warnings Exact identifier application number: M020 Vertra Pearl White Face Stick SPF 50 PADIMATE O, TITANIUM DIOXIDE Eai-jr 286, Inc b69a75e0-8724-35ae-e053-2a95a90a5f34 2025-10-07 Warnings Exact identifier application number: M020 Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige TITANIUM DIOXIDE EAI-JR 286, Inc. b9ea12e8-6ed9-d805-e053-2a95a90aa107 2025-10-07 Warnings Exact identifier application number: M020 SPF50 Sunscreen SUNSCREEN KINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD b3cde609-7d62-2ac7-e053-2a95a90a26b3 2025-10-07 Exact identifier application number: M020 Summer Face Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUMMER GELEE LLC fe256ff4-cb92-4262-8ab9-7cc912e0af22 2025-10-06 Warnings Exact identifier application number: M020 Sun Veil Broad Spectrum SPF50 ZINC OXIDE MONAT GLOBAL CORP 3ba28de7-74a2-5cde-e063-6394a90add26 2025-10-06 Warnings Exact identifier application number: M020 Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige TITANIUM DIOXIDE Toshiki Pigment Co., Ltd. b9eba15f-493a-43c9-e053-2995a90a0451 2025-10-06 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 49358-570-01 49358057001 1 TUBE in 1 CARTON (49358-570-01) / 50 mL in 1 TUBE 1 tube 2023-07-01 No No Current 49358-570-02 49358057002 1 TUBE in 1 CARTON (49358-570-02) / 100 mL in 1 TUBE 1 tube 2023-07-01 No No Current