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 199 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOLDEN ROSE GLOW KISS TINTED LIP BALM CHOCO CAKEAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI8be1c27c-7988-47c4-b613-3bc86f53981e2025-08-08WarningsExact identifier
application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM STRAWBERRYAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIa3c8d778-ce9c-46eb-a0c3-6886eb1d39342025-08-08WarningsExact identifier
application number: M020
GOLDEN ROSE glow kiss TINTED LIP BALM CHERRY JUICEAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI6cdb0b61-a9c2-4a78-9752-8e7aedaeef452025-08-08WarningsExact identifier
application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM BERRY PINKAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIf1b6c068-06d2-4a44-8199-7111d1b6a0d62025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER COOKIE SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI0274f5f1-1ee1-48a5-af7a-deb3aa3a34d72025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER ICE MINT SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIa355777b-2cce-48ce-acc6-2aa7f154c4ba2025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER RASPBERRY SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI5443202c-4f88-4063-a227-c50abbd480d62025-08-08WarningsExact identifier
application number: M020
SUNSCREEN SPF50ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, TITANIUM DIOXIDEGuangzhou Tinsun Biotechnology Company Limited3bc1c6e9-1dd5-d7c6-e063-6394a90ad89e2025-08-07WarningsExact identifier
application number: M020
Lipid Shield SPF 30ZINC OXIDEAllure Labs3bce820a-147b-5d8b-e063-6294a90a570d2025-08-07WarningsExact identifier
application number: M020
GR LONGSTAY Matte Face Powder SPF 15OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI62759398-4935-4732-b950-cfbeab82bc5a2025-08-07WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry-Touch Sunscreen MAX Broad Spectrum SPF 100 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC3bac8d0a-8726-46c3-e063-6294a90a10752025-08-06WarningsExact identifier
application number: M020
Tanning Club Golden Glow Tanning Oil SPF 15AVOBENZONE, OCTISALATE, OCTOCRYLENETANNING CLUB, LLC33478e28-b079-4e52-9924-845d127be2862025-08-06WarningsExact identifier
application number: M020
Tanning Club Everyday Sunscreen SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONETANNING CLUB, LLC805048c4-f2b3-4d35-8674-f44cf3d1a4b52025-08-06WarningsExact identifier
application number: M020
PoolBar I Scream For Sunscreen SPF 50 Coconut and VanillaAVOBENZONE, OCTISALATE, OCTOCRYLENEPOOLBARdeddb91d-b2d5-4d97-bc38-5c11abde9d432025-08-06WarningsExact identifier
application number: M020
PoolBar I Scream For Sunscreen SPF 30 Coconut and VanillaAVOBENZONE, OCTISALATE, OCTOCRYLENEPOOLBAR7f16b91d-29e4-4c21-a008-5dcc858c83d82025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 17W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L053cb3cd-dd16-4d08-b347-a4349fa37c072025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 14W Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L7bf90657-b636-41d6-b96c-88d174989f5b2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 15N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lda7e19cd-6a8b-47df-bfc9-2f0f11b7955c2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 16N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf7a1d379-6de0-4be4-84a9-e0ebef332bef2025-08-06WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 18N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L671be8a6-51b7-45d2-9fff-c7736d2eea3e2025-08-06WarningsExact 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