Solar SPF 40

Product NDC
49358-577
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 · 14 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 packagepackage49358-577-01IInactivated 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 packagepackage49358-577-01IInactivated 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 packagepackage49358-577-01IInactivated 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 packagepackage49358-577-01IInactivated 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 packagepackage49358-577-01UExcluded 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 packagepackage49358-577-01UExcluded 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 packagepackage49358-577-01UExcluded 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 296 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Giorgio Armani Power Fabric Plus Weightless Matte Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATESICOS ET CIE3b49a970-653b-4256-b2d3-4e065db638492024-06-24WarningsExact identifier
application number: M020
Giorgio Armani Power Fabric Plus Weightless Matte Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATEL'Oreal USA Products Inc.1b851e19-add0-437b-86e4-e88a10a1e7742024-06-24WarningsExact identifier
application number: M020
Exel Clarifying Line SPF 50OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDEBiocosmetica Exel Argentina SRLe65a68f6-d1b7-4cbf-a3f8-5cc04036221a2024-06-23WarningsExact identifier
application number: M020
Bitchstix Citrus Orange Broad Spectrum SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1b6bf419-554c-86a7-e063-6294a90a5a7e2024-06-21WarningsExact identifier
application number: M020
OS-01 Body SPF 30ZINC OXIDEAllure Labs1b582f4e-553f-a511-e063-6294a90af3c02024-06-20WarningsExact identifier
application number: M020
Seaweed Bath Co Playful Papaya Kids Sunscreen SPF 50ZINC OXIDEThe Seaweed Bath Co.65c9c131-2545-4d88-aa9a-85197b654d742024-06-19WarningsExact identifier
application number: M020
Protectif Fair TintZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.1a8c8804-1d6b-b5a5-e063-6394a90a12602024-06-18WarningsExact identifier
application number: M020
EB-5 Super Hydrating Anti-Aging SPF-50OCTOCRYLENE, ZINC OXIDE, OCTISALATELIFE O, INC.b9521112-d119-4d48-8504-4e46b434f76f2024-06-17WarningsExact identifier
application number: M020
Burts Bees SPF 30 Untinted Lip Balm Beaches and CreamBURTS BEES SPF 30 UNTINTED LIP BALM BEACHES AND CREAMAutumn Harp1ac89261-eeae-567c-e063-6294a90ad45f2024-06-13WarningsExact identifier
application number: M020
Protectif UntintedZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.1acd3f09-87f2-75e4-e063-6394a90a0cd92024-06-13WarningsExact identifier
application number: M020
Mara Clear Skin Mineral Milk Acne TreatmentSALICYLIC ACIDMara Beauty LLC3823024e-81b4-4e29-af76-82231e09407c2024-06-13WarningsExact identifier
application number: M020
BOB KIDS SPF 30 Zinc onlyZINC OXIDESPF Ventures, LLC1aae0291-f16f-7840-e063-6394a90a34432024-06-12WarningsExact identifier
application number: M020
Glossier Invisible Shield SPF 50GLOSSIER INVISIBLE SHIELD SPF 50Autumn Harp1ab39eae-06e9-0e4c-e063-6394a90ad8aa2024-06-12WarningsExact identifier
application number: M020
Thinksport SPF 50ZINC OXIDEthinkOperations,LLC2e83e382-8eb0-40f2-bdca-2db5e184661e2024-06-10WarningsExact identifier
application number: M020
Thinkkids SPF 50ZINC OXIDEthinkOperations,LLC09f9d9bb-c08b-401c-bbf1-640f1c8ec6782024-06-07WarningsExact identifier
application number: M020
NAELI Day Moisturizer Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEALLI LLCf2cebdc7-c96e-46cf-9b5c-b4965ddd2aec2024-06-06WarningsExact identifier
application number: M020
Youth 3 Activating BB Cream SPF 30 MediumZINC OXIDE, TITANIUM DIOXIDEShaklee Corporationccc80ea4-f270-4fd4-970c-eaa63df936e42024-06-06WarningsExact identifier
application number: M020
Thinkbaby SPF 50ZINC OXIDEthinkOperations,LLCf2788a1a-daf6-4b7d-8333-585a380ebe572024-06-05WarningsExact identifier
application number: M020
RMS SUNCOVERUP SUPER TINT SPF 50 ALABASTERZINC OXIDERms organics LLC1a11c884-d6ba-d77f-e063-6394a90a5bd22024-06-04WarningsExact identifier
application number: M020
toty Solaria BodyOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDECHIPICAN LLC1a121b17-3621-6bc1-e063-6394a90ac9a12024-06-04WarningsExact 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