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.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 75936-628-02 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 75936-628-02 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 75936-628-02 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 75936-628-02 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 75936-628-02 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 75936-628-02 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 75936-628-02 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 75936-628-02 | U | Excluded because listing certification expired | 0efc9e666f02… | 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 |
|---|---|
| HOMOSALATE | 7 g/100mL |
| ZINC OXIDE | 13.58 g/100mL |
| OCTISALATE | 5 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4X49Y0596W | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
| V06SV4M95S | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0801287f-0df5-4303-e063-6394a90a503b | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 75936-628-02 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9571-d83d-e063-dadaa90ab31f | Protec(tint) SPF 50 |
| 75936-628-02 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9571-d83d-e063-dadaa90ab31f | Protec(tint) SPF 50 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75936-628-01 | ProtecTINT 26W | 35 mL in 1 TUBE | CREAM | 35 | 2 | |
| 75936-628-02 | ProtecTINT 26W | 1 in 1 BOX | CREAM | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 75936-628 | PROTECTINT 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] | 1 | Current NDC, 2 package rows | 20231129_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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sei Bella Tinted BB Moisturizing Creme Medium to Deep 450 W | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | 68e30255-564f-3b4a-e053-2991aa0ab3f7 | 2025-12-31 | Warnings | M020 |
| Sei Bella Tinted BB Moisturizing Creme Medium 320 C | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | 68e2e541-c596-0f12-e053-2991aa0a4ab2 | 2025-12-31 | Warnings | M020 |
| Sei Bella Tinted BB Moisturizing Creme Light to Medium 160 N | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | 68e20c57-7b30-4e96-e053-2991aa0aab3e | 2025-12-31 | Warnings | M020 |
| Sun Shades Lip Balm Pina Colada | AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% | Melaleuca Inc. | 16d0d2d2-b9c4-4491-8d8a-815843d342e8 | 2025-12-31 | Warnings | M020 |
| Sun Shades Lip Balm Mountain Mint | AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% | Melaleuca Inc. | 326d9623-0e67-43bd-83f8-ee7dfa3bdbe8 | 2025-12-31 | Warnings | M020 |
| Sun Shades Lip Balm Vanilla Bean | AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% | Melaleuca Inc. | 2037cc9d-b11b-47d6-8d65-c0f9decc8ba7 | 2025-12-31 | Warnings | M020 |
| Sun Shades Mineral Plus Sunscreen with Zinc Oxide | OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5% | Melaleuca Inc. | 8886cbd0-ed2b-4a2b-a724-a0d4f12296c9 | 2025-12-31 | Warnings | M020 |
| Eucerin Daily Hydration | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | 798cbf7f-b93d-49c8-b1c1-216486e57ea5 | 2025-12-31 | Warnings | M020 |
| Eucerin Face immersive Hydration | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | fe0b3717-f472-3a61-e053-6394a90a44fb | 2025-12-31 | Warnings | M020 |
| NIVEA MEN Age Defense Face Moisturizer | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | 27cbec3e-e811-6498-e063-6394a90ada49 | 2025-12-31 | Warnings | M020 |
| Nivea Men Maximum Hydration Face | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | f1276b11-6683-e982-e053-2a95a90a7803 | 2025-12-31 | Warnings | M020 |
| Nivea Men Sensitive Protective | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | f6cff3d1-cca5-4b3e-a481-0c4def90684c | 2025-12-31 | Warnings | M020 |
| Nivea Smoothness Lip Care | AVOBENZONE,OCTOCRYLENE | Beiersdorf Inc | c28e327d-ad39-9bd6-e053-2a95a90a04eb | 2025-12-31 | Warnings | M020 |
| BOTANICAL SOOTHING SPF-30 | OCTINOXATE, OCTISALATE, ZINC OXIDE | CONTROL CORRECTIVE SKINCARE INC | 00a923fe-e6da-420e-a705-4773ecc2176b | 2025-12-31 | Warnings | M020 |
| AROMA MATTE DAY SUNSCREEN SPF-30 | OCTINOXATE, OCTISALATE, ZINC OXIDE | CONTROL CORRECTIVE SKINCARE INC | f822f3ec-3c57-100a-e053-6294a90ab0ec | 2025-12-31 | Warnings | M020 |
| CONTROL CORRECTIVE TINTED MOISTURIZER SPF-30 SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | CONTROL CORRECTIVE SKINCARE INC | 8ac09149-f7e7-40a8-b306-98964d0cd6e3 | 2025-12-31 | Warnings | M020 |
| CONTROL CORRECTIVE SUNSCREEN SPF-30 | OCTINOXATE, OCTISALATE, ZINC OXIDE | CONTROL CORRECTIVE SKINCARE INC | e389b2bc-bb1c-443a-9bf6-c6d96380f378 | 2025-12-31 | Warnings | M020 |
| CONTROL CORRECTIVE INTENSIVE SKIN BRIGHTENING SPF-30 SUNSCREEN | OCTINOXATE, OCTISALATE, ZINC OXIDE | CONTROL CORRECTIVE SKINCARE INC | 61b6dab9-3378-4206-bf1f-6f385a9c882c | 2025-12-31 | Warnings | M020 |
| Blue Lizard Sensitive SPF 50 Sunscreen | TITANIUM DIOXIDE AND ZINC OXIDE | Crown Laboratories | 32d78048-d281-1d80-e063-6394a90aec19 | 2025-12-31 | Warnings | M020 |
| DAYWEAR ANTI OXIDANT 72H-HYDRATION SORBET CREME BROAD SPECTRUM SPF 15 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | ESTEE LAUDER INC | df535004-c94c-4a28-ad20-78bd1741e39f | 2025-12-31 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 75936-628-01 | 75936062801 | 35 mL in 1 TUBE | 35 ml | Historical | |||
| 75936-628-02 | 75936062802 | 1 TUBE in 1 BOX (75936-628-02) / 35 mL in 1 TUBE (75936-628-01) | 1 tube | 2023-11-22 | No | No | Current |