FDA.reportPublic FDA data

ProtecTINT 26W

Product NDC
75936-628
11-digit product format
759360628
Labeler code
75936
Product ID
75936-628_40975baf-b82b-0621-e063-6294a90a217d
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octisalate, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Supergoop, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-22
Substance
HOMOSALATE; ZINC OXIDE; OCTISALATE
Active strength
7; 13.58; 5 g/100mL; g/100mL; g/100mL
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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage75936-628-02IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage75936-628-02IInactivated 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 packagepackage75936-628-02IInactivated 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 packagepackage75936-628-02IInactivated 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 packagepackage75936-628-02IInactivated 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 packagepackage75936-628-02UExcluded 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 packagepackage75936-628-02UExcluded 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 packagepackage75936-628-02UExcluded 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
ProtecTINT 26W
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE7 g/100mL
ZINC OXIDE13.58 g/100mL
OCTISALATE5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
4X49Y0596WInternal UNII lookup
V06SV4M95SInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0801287f-0df5-4303-e063-6394a90a503bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75936-628-022025-01-30C16284748780-12cef2736-9571-d83d-e063-dadaa90ab31fProtec(tint) SPF 50
75936-628-022025-01-30C16284748780-12cef2736-9571-d83d-e063-dadaa90ab31fProtec(tint) SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75936-628-01ProtecTINT 26W35 mL in 1 TUBECREAM352
75936-628-02ProtecTINT 26W1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75936-628PROTECTINT 20C (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 26W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 32N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 34C (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 58W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 10N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 24N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 22W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 30W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 46N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 42C (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 52N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 14N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 40W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM [SUPERGOOP, LLC]1Current NDC, 2 package rows20231129_0801287f-0df5-4303-e063-6394a90a503b.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 244 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Refreshing Water Hydration Stick SPF 50AVOBENZONE OCTISALATE HOMOSALATE OCTOCRYLENECOOLA LLC6da037f8-bedb-467a-b534-e44752120f2c2024-12-27WarningsExact identifier
application number: M020
Nu Skin ageLOC Radiant Day Broad Spectrum SPF 22AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENENSE Products, Inc.649a9c28-bfd4-404c-90d5-5d0ea8c7b6452024-12-27WarningsExact identifier
application number: M020
Kiehls Since 1851 Activated Sun Protector For Face and Body Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc87496037-36ca-4c5f-973f-46626cf4096e2024-12-27WarningsExact identifier
application number: M020
PORESCREEN SPF40ZINC OXIDEDermalogica, LLC.37a7362a-b251-4d3a-a957-65d8f338fa122024-12-27WarningsExact identifier
application number: M020
COOLA Classic Face Sunscreen Fragrance-Free SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC12ff4689-f7e2-49db-8848-608c61b41ef02024-12-27WarningsExact identifier
application number: M020
NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINTZINC OXIDEBentley Laboratories, LLC6edd51e5-1c42-4e66-b5ca-abfea2dad8f82024-12-27WarningsExact identifier
application number: M020
Tone Control Morning Cream SPF 15OCTOCRYLENE AND OCTISALATE CREAMBentley Laboratories, LLCb4e3cd1c-ae42-4995-a314-96d24d328e412024-12-27WarningsExact identifier
application number: M020
ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light)ZINC OXIDEZO Skin Health, Inc.be25489e-c3bf-77c5-e053-2a95a90a30de2024-12-27WarningsExact identifier
application number: M020
COOLA Classic Body Sunscreen Tropical Coconut SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC55ad5d2f-a855-491e-a287-13689f8abff12024-12-27WarningsExact identifier
application number: M020
RODAN and FIELDS UNBLEMISHTITANIUM DIOXIDE, ZINC OXIDEBentley Laboratories, LLC2b3b6b62-364f-4aba-8024-3a73752b4c562024-12-27WarningsExact identifier
application number: M020
Powerbright Moisturizer SPF 50OCTOCRYLENE, HOMOSALATE, AVOBENZONE, AND OCTISALATEDermalogica, LLC.02c731ee-c5cb-4158-9b1f-e826593c35262024-12-27WarningsExact identifier
application number: M020
INVISIBLE PHYSICAL DEFENSE SPF30ZINC OXIDEDermalogica, Inc.2e5e6861-25ea-4605-8e59-41d852c002b72024-12-27WarningsExact identifier
application number: M020
COOLA CLASSIC FACE SUNSCREEN Cucumber Broad Spectrum SPF 30AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECOOLA LLCdec3b0d1-f06e-4acf-8ba2-64167e774abc2024-12-27WarningsExact identifier
application number: M020
Clearing Defense SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEDermalogica, Inc.2388ae53-0a61-43c0-8936-c639887a56492024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c5efde-42e3-e4fc-e063-6394a90a491d2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d832-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Morphe SPF 30 Broad Spectrum Sunsetter SettingOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION0d34406f-9dd0-3909-e063-6394a90ab9f92024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c64cc0-be42-c210-e063-6394a90a6d9a2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c61c42-edda-1ebd-e063-6294a90aee132024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d839-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75936-628-017593606280135 mL in 1 TUBE35 mlHistorical
75936-628-02759360628021 TUBE in 1 BOX (75936-628-02) / 35 mL in 1 TUBE (75936-628-01) 1 tube2023-11-22NoNoCurrent