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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49358-570-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49358-570-02IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49358-570-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49358-570-02IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49358-570-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49358-570-02IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49358-570-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49358-570-02IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49358-570-01UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49358-570-02UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49358-570-01UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49358-570-02UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49358-570-01UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49358-570-02UExcluded because listing certification expired0efc9e666f02…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
IngredientStrength
TITANIUM DIOXIDE20 mg/mL
ZINC OXIDE170 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f8e178d6-058c-462a-8e59-6721f28ad040Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49358-570-01Mineral Creme SPF 50Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)50 mL in 1 TUBECREAM502
49358-570-01Mineral Creme SPF 50Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)1 in 1 CARTONCREAM12
49358-570-02Mineral Creme SPF 50Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)100 mL in 1 TUBECREAM1002
49358-570-02Mineral Creme SPF 50Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49358-570MINERAL CREME SPF 50 MINERAL CREME SPF 50 BROAD SPECTRUM UVA-UVB SUNSCREEN WATER RESISTANT (80 MIN) (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MDSOLARSCIENCES]1Current NDC, 4 package rows20230910_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 24 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lancome Paris Teint Idole Ultra Wear Care and Glow Skincare Foundation Broad Spectrum SPF 27 SunscreenENSULIZOLEL'Oreal USA Products Inc79fd34ad-cd4a-4fa0-9b7c-e0a2252654da2026-05-27WarningsExact identifier
application number: M020
Lancome Paris Teint Idole Ultra Wear Care and Glow Skincare Foundation Broad Spectrum SPF 27 SunscreenENSULIZOLESICOS ET CIE3ff286c0-4515-4cab-9b93-a782545b2f362026-05-27WarningsExact identifier
application number: M020
MyDerm SPF 50HOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00%Inspec Solutions LLC1a995cda-dc67-419c-90e6-c61050c760982026-05-27WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkleAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc2b634b3f-0d2b-4ae4-b302-9befb14a90df2026-05-27WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkleAVOBENZONE, OCTISALATE AND OCTOCRYLENESICOS ET CIEfce593a2-f4ed-46c1-81a1-be3941649e472026-05-27WarningsExact identifier
application number: M020
BROTEGE Good Boy Protection SPF 15 and Retinol Daily MoisturizerBENZOPHENONE-3, BUTYLE METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENESpa de Soleil1f47e508-58dd-fab4-e063-6394a90a668a2026-05-27WarningsExact identifier
application number: M020
GOONGBE Waterful SunLotion Mild SPF 40ZINC OXIDEZero to Seven Inc.1e86edfd-d089-ba41-e063-6294a90a67092026-05-27WarningsExact identifier
application number: M020
GOONGBE Baby Easy Wash SunLotion SPF 30ZINC OXIDEZero to Seven Inc.1e86c2a9-a5c3-95cb-e063-6394a90a014d2026-05-27WarningsExact identifier
application number: M020
Stream2Sea Reef Safer Mineral Sunscreen SPF40ZINC OXIDEStream2Sea, LLC52e73c23-75ec-d8a8-e063-6294a90a54932026-05-27WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - RosewoodZINC OXIDERiversol52b8f588-8383-634e-e063-6294a90a8f8b2026-05-26WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - PoppyZINC OXIDERiversol52b92725-6d9a-768a-e063-6394a90ac9332026-05-26WarningsExact identifier
application number: M020
Odacite Nourishing Lip Serum - Jazzy BerryZINC OXIDEOdacite52b97fb0-84d6-a408-e063-6294a90a9be92026-05-26WarningsExact identifier
application number: M020
Odacite Nourishing Lip Serum - True NudeZINC OXIDEOdacite52b9be2a-4958-f537-e063-6294a90a7a1b2026-05-26WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - PoppyZINC OXIDESolesence, Inc.52ba09cb-edcc-a405-e063-6394a90a6aab2026-05-26WarningsExact identifier
application number: M020
Odacite Nourishing Lip Serum - Bubble GumZINC OXIDEOdacite52b9fb0a-0554-0de2-e063-6294a90a09d32026-05-26WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - RosewoodZINC OXIDESolesence, Inc.52ba07f1-b74e-a4b6-e063-6394a90a74732026-05-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 50 SunscreenZINC OXIDESKIN DAMAGE INC.52ba2f12-839f-cea1-e063-6394a90a5ae62026-05-26WarningsExact identifier
application number: M020
Odacite Color Balm - Bronze JolieZINC OXIDEOdacite52ba360e-375c-0469-e063-6294a90a020e2026-05-26WarningsExact identifier
application number: M020
Odacite Color Balm - Golden HourZINC OXIDEOdacite52ba8e03-1944-b73d-e063-6294a90a50392026-05-26WarningsExact identifier
application number: M020
Odacite Color Balm - Sienna RoseZINC OXIDEOdacite52ba7f12-2b79-79cf-e063-6294a90a92d82026-05-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49358-570-01493580570011 TUBE in 1 CARTON (49358-570-01) / 50 mL in 1 TUBE1 tube2023-07-01NoNoCurrent
49358-570-02493580570021 TUBE in 1 CARTON (49358-570-02) / 100 mL in 1 TUBE1 tube2023-07-01NoNoCurrent