FDA.reportPublic FDA data

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49358-577-012025-06-05C16284748780-12cef2736-b6a3-d83d-e063-dadaa90ab31fSolar Stick™ SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Sunscreen
49358-577-012025-01-30C16284748780-12cef2736-b6a3-d83d-e063-dadaa90ab31fSolar Stick™ SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Sunscreen

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 294 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Silk Line Silk Day Cream SPF 15OCTINOXATE, OCTOCRYLENE, OCTISALATEBiocosmetica Exel Argentina SRLb2965aba-fcde-16f6-e053-2995a90aa9d82024-06-30WarningsExact identifier
application number: M020
Sun Shield On-the-Glow Sheer Stick SPF40AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1c237d5a-1663-e9a1-e063-6294a90a6a242024-06-30WarningsExact identifier
application number: M020
Exel Clarifying Line SPF 50OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDEExelencia importers0d6d4098-4121-477e-b404-3ab18628ed682024-06-30WarningsExact identifier
application number: M020
Silk Line Silk Day Cream SPF 15OCTINOXATE, OCTOCRYLENE, OCTISALATEExelencia Importers, Corp.b2d35086-748b-55d0-e053-2995a90a18982024-06-30WarningsExact identifier
application number: M020
Maybelline New York Dream Fresh BB Beauty Balm Skin Perfector Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc28c51c59-dbfb-45e5-b536-6e5d5c5560d62024-06-28WarningsExact identifier
application number: M020
Sun Shield Body Glow SPF50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEKoco Life LLC180aa4d5-6dac-e658-e063-6394a90a32872024-06-28WarningsExact identifier
application number: M020
Rose Gold Sun Shield Body Glow SPF45AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1bf7d147-7051-2e76-e063-6294a90a1d132024-06-28WarningsExact identifier
application number: M020
Golden Amber Sun Shield Body Glow SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC1bf97569-024a-9ef1-e063-6394a90a28222024-06-28WarningsExact identifier
application number: M020
Jergens Natural Glow Face Daily Moisturizer for Fair/Medium SkinAVOBENZONE, OCTISALATE, OCTOCRYLENEKao USA Inc.365a98e0-737b-12b3-e054-00144ff8d46c2024-06-28WarningsExact identifier
application number: M020
Antioxidant Face Shield Mineral SPF30ZINC OXIDEKoco Life LLC1c31a971-0402-e12a-e063-6294a90ac91d2024-06-28WarningsExact identifier
application number: M020
Sun Essentials SPF Duo KitAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1c329b86-664e-de1f-e063-6394a90a7c232024-06-28WarningsExact identifier
application number: M020
IT COSMETICS YOUR SKIN BUT BETTER CC PLUS NUDE GLOW Color Correcting Medium Coverage Skin Tint plus Brightening Glow Serum plus Broad Spectrum SPF 40 SunscreenHOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Ince879c055-9611-46a2-bcf6-8dd0a29a31292024-06-28WarningsExact identifier
application number: M020
Lancome Paris Absolue Makeup Broad Spectrum SPF 20 Sunscreen Absolute Replenishing Makeup for Dry and Very Dry SkinOCTINOXATEL'Oreal USA Products Inc90326e7e-8fdf-4221-afc0-208774d8ba6f2024-06-28WarningsExact identifier
application number: M020
LOreal Paris Collagen Moisture Filler Ultra Light Moisturizing Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc21fdc5e-236a-4a8e-ad59-1d9cd75074242024-06-28WarningsExact identifier
application number: M020
Kiehls Ultra Facial Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc6925c546-056e-4be8-b4e9-55da0b6b62b32024-06-28WarningsExact identifier
application number: M020
LOreal Paris Age Perfect Radiant Foundation Broad Spectrum SPF 50 Sunscreen with Antioxidants plus Concentrated SerumHOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc799c547c-a17a-43ee-92fc-061b5ec8a40c2024-06-28WarningsExact identifier
application number: M020
LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Incf6457973-3718-44cd-a764-de0b089d4eee2024-06-28WarningsExact identifier
application number: M020
LOreal Paris Visible Lift Serum Absolute Advanced Makeup Broad Spectrum SPF 17 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc8598d56b-adcd-48e8-b6fc-77bc934009c72024-06-27WarningsExact identifier
application number: M020
MAYBELLINE NEW YORK INSTANT AGE REWIND ERASER TREATMENT MAKEUP OCTINOXATE BROAD SPECTRUM SPF 20 SUNSCREEN PLUS PROVITAMIN B5OCTINOXATEL'Oreal USA Products Inc12ec5a93-8c24-4ac9-94df-910dd8137e002024-06-27WarningsExact identifier
application number: M020
Kiehls Since 1851 Dermatologist Solutions AutoTone Discoloration and UV Solution Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc6dbbc8ce-9457-4405-bb38-aa0c7550c62c2024-06-27WarningsExact 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