ProtecTINT 58W
- Product NDC
- 59735-910
- 11-digit product format
- 597350910
- Labeler code
- 59735
- Product ID
- 59735-910_4f77c110-9e98-6fdf-e063-6394a90a3c7c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Homosalate, Octisalate, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- PML NYC, 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
- 2027-12-31
- Current FDA listing
- Yes
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 58W
- Listing expiration
- 2027-12-31
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 |
|---|---|
| 1bcc9f71-820f-eba2-e063-6394a90a3305 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59735-910-01 | ProtecTINT 58W | 35 mL in 1 TUBE | CREAM | 35 | 3 | |
| 59735-910-02 | ProtecTINT 58W | 1 in 1 BOX | CREAM | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59735-910 | 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 [MANA PRODUCTS, INC.] | 1 | Current NDC, 2 package rows | 20240628_1bcc9f71-820f-eba2-e063-6394a90a3305.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 |
|---|---|---|---|---|---|---|
| Poolside Butter Screen SPF 30 Sunscreen Butter | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | I World LLC | ae838725-79ab-4c17-905b-d4138ad6af1f | 2026-01-05 | Warnings | M020 |
| Poolside Bronze Service Instant Bronzing Sunscreen SPF 30 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE | I World LLC | b98a9cec-3c48-4614-b091-4e59fa7d196e | 2026-01-05 | Warnings | M020 |
| Poolside Orange Creme SPF 30 Sunscreen Oil Mist | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | I World LLC | 5a9f8888-529d-40d7-9489-baa5ff657cb4 | 2026-01-05 | Warnings | M020 |
| Yon-Ka 50 Mineral Fluid | ZINC OXIDE | Laboratoire MULTALER Yon-Ka | 47a8c8b2-30ff-0d40-e063-6294a90ac461 | 2026-01-05 | Warnings | M020 |
| SHISEIDO FUTURE solution LX UNIVERSAL DEFENSE E | OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | 6d2f82d5-b3af-44af-b6b0-de96a4cd95fc | 2026-01-05 | Warnings | M020 |
| SHISEIDO SPORTS BB LIGHT | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 260a3eab-8fe6-4259-8dcc-3706ca1f6881 | 2026-01-05 | Warnings | M020 |
| SHISEIDO VITAL PERFECTION UPLIFTING AND FIRMING DAY | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND HOMOSALATE | SHISEIDO AMERICAS CORPORATION | 4a16dbb7-e860-4aae-8e8b-67abbe8295bd | 2026-01-05 | Warnings | M020 |
| SHISEIDO ULTIMATE SUN PROTECTOR | OCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | c656792a-e1ed-478d-b501-9bdc92d16eca | 2026-01-05 | Warnings | M020 |
| SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 110 ALABASTER | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 0a214b6b-69a7-4cb9-9095-6fcf2b6945de | 2026-01-05 | Warnings | M020 |
| SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAR | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | fb6ac681-ff74-4420-a4f6-843d5f2b6d6b | 2026-01-05 | Warnings | M020 |
| CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE | SHISEIDO AMERICAS CORPORATION | 207e2035-5f31-4745-a801-b386b040b738 | 2026-01-05 | Warnings | M020 |
| Hawaiian Blend Essential Zinc SPF 50 | ZINC OXIDE, TITANIUM DIOXIDE | The Islander Group | 47aa8605-e536-b998-e063-6394a90ad9f0 | 2026-01-05 | Warnings | M020 |
| SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHT | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | bf736c5b-fc33-4cd5-8d18-03929f739d76 | 2026-01-05 | Warnings | M020 |
| SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Golden 1 | OCTINOXATE | SHISEIDO AMERICAS CORPORATION | 8a9294c2-3933-4f9c-b7e6-1f446f441a16 | 2026-01-05 | Warnings | M020 |
| Shiseido Future Solution LX Total Protective | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE | SHISEIDO AMERICAS CORPORATION | 6de17911-4bce-46c9-906b-07d899a36ceb | 2026-01-05 | Warnings | M020 |
| CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES IVORY | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | c4028089-677f-4d51-9c8b-3892ff1649e0 | 2026-01-05 | Warnings | M020 |
| SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 110 | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 8a0da327-a805-4ef9-b69a-14bf7278a81a | 2026-01-05 | Warnings | M020 |
| CLE DE PEAU BEAUTE CORRECTING VEIL n | ENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | fd9b42e4-6f9d-45a9-bee3-ac1bc4b35252 | 2026-01-05 | Warnings | M020 |
| SHISEIDO THE MAKEUP FOUNDATION I20 | TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 3c024fe9-2983-4857-a55a-13406158e3a9 | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE RADIANT FLUID FOUNDATION BF10 | TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | b2b55a7a-1f68-429d-ba70-5bb6c7e0d8d3 | 2026-01-05 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 59735-910-01 | 59735091001 | 35 mL in 1 TUBE | 35 ml | Historical | |||
| 59735-910-02 | 59735091002 | 1 TUBE in 1 BOX (59735-910-02) / 35 mL in 1 TUBE (59735-910-01) | 1 tube | 2023-11-22 | No | No | Current |