Solar SPF 40

Product NDC
49358-577
Requested package NDC
49358-577-01
11-digit product format
493580577
Labeler code
49358
Product ID
49358-577_36d8788d-8533-df6d-e063-6394a90add46
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide and Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
MDSolarSciences
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
81; 60 mg/g; mg/g
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 · 7 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded 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
Solar SPF 40
Brand name suffix
Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE81 mg/g
ZINC OXIDE60 mg/g

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
6ce602bb-c1f4-43c1-ae61-0f05d7952db3Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49358-577-01Solar SPF 40Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen1 in 1 CARTONSTICK12
49358-577-01Solar SPF 40Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen17 g in 1 TUBESTICK172

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49358-577SOLAR SPF 40 BROAD SPECTRUM SPF 40 WATER RESISTANT (80 MIN) MINERAL SUNCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1Current NDC, 2 package rows20230912_6ce602bb-c1f4-43c1-ae61-0f05d7952db3.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 196 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NV6a398dad-2fb9-4cdb-86c5-2a392b88f29b2025-08-13WarningsExact identifier
application number: M020
SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 40ZINC OXIDEALL THE RAJE, LLC9ffbd53b-1295-42b4-9cd5-18cbb75921d02025-08-13WarningsExact identifier
application number: M020
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 02 Umber, BistreZINC OXIDEPower Beauty Co.2e6eac42-0b70-44ea-e063-6294a90a49f82025-08-13WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE/OCTOCRYLENE/OXYBENZONEEdgewell Personal Care Brands LLC3c414e9b-6c3e-2c8d-e063-6394a90af4a62025-08-13WarningsExact identifier
application number: M020
Earth Mama Baby Mineral Sunscreen SPF 40ZINC OXIDEEleeo Brands LLC3c443347-0134-8c87-e063-6294a90a80462025-08-13WarningsExact identifier
application number: M020
Earth Mama Baby Face Mineral Sunscreen Stick SPF 40ZINC OXIDEEleeo Brands LLC3a22f0b9-2d6d-6230-e063-6294a90adf312025-08-13WarningsExact identifier
application number: M020
Earth Mama Lady Face Tinted Mineral Sunscreen Stick SPF 40ZINC OXIDEEleeo Brands LLC3c4567d6-879e-f995-e063-6394a90a319f2025-08-13WarningsExact identifier
application number: M020
Silk ScreenTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c457455-b9b1-546b-e063-6294a90a41f62025-08-13WarningsExact identifier
application number: M020
Earth Mama Tinted Mineral Sunscreen SPF 40ZINC OXIDEEleeo Brands LLC3c455d29-df4e-f4d5-e063-6394a90a97ba2025-08-13WarningsExact identifier
application number: M020
Baby Bum Mineral 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3c470ff8-37d6-a729-e063-6294a90aa5252025-08-13WarningsExact identifier
application number: M020
Sun Bum 50 Mineral Sunscreen 1 OZZINC OXIDESun Bum, LLC3c483d04-8942-5269-e063-6294a90a38812025-08-13WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE/OCTOCRYLENE/OXYBENZONEEdgewell Personal Care Brands LLC3c49c623-47c6-4dc9-e063-6294a90a00962025-08-13WarningsExact identifier
application number: M020
100% MINERAL SUNSCREEN100% MINERAL SUNSCREENGuangzhou Pallas Cosmetics Co.,Ltd.3c4a3b41-9183-3835-e063-6394a90aea612025-08-13WarningsExact identifier
application number: M020
ERBORIAN CC CREME Color Correcting SPF 25 FAIROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L4443d4e6-bdc9-4547-9189-e94e9e0bdd2d2025-08-12WarningsExact identifier
application number: M020
ERBORIAN CC Red Correct Color Correcting SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&La6cd16cc-5fe3-41b5-b724-83e469cd4d5e2025-08-12WarningsExact identifier
application number: M020
ERBORIAN CC CREME Color Correcting SPF 25 BRONZEOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L4aa12cf0-0c48-4b40-9c9a-bd50523cce8a2025-08-12WarningsExact identifier
application number: M020
ERBORIAN CC CREME Color Correcting SPF 25 MEDIUMOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L5bdaa149-47aa-40ac-b17a-ea6d290998622025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1dda967c-2d69-8948-e063-6294a90ad2a42025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 15mL with wild Rosella SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD24e9a9b8-41ba-123a-e063-6394a90a73cb2025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1dd9fe59-9e40-fd06-e063-6394a90a4ca22025-08-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49358-577-01493580577011 TUBE in 1 CARTON (49358-577-01) / 17 g in 1 TUBE1 tube2023-07-01NoNoCurrent