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 |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
| V06SV4M95S | Internal UNII lookup |
| 4X49Y0596W | 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 |
|---|---|---|---|---|---|---|
| Eucerin Sensitive Mineral SPF 50 Sunscreen | ZINC OXIDE | Beiersdorf Inc | cdb25154-e4e3-efc7-e053-2a95a90a2df6 | 2025-11-10 | Warnings | M020 |
| ESSENCE BY CATHERINE HINDS Broad Spectrum MINERAL PROTECTION SPF 50 | ZINC OXIDE | Catherine Hinds Company, Inc. | 956e6643-51c9-49c4-bd68-f5ee1b0ae4e0 | 2025-11-10 | Warnings | M020 |
| GoodSense SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Geiss, Destin, & Dunn, Inc. | c85d59a1-6ae1-bb2e-e053-2995a90af20e | 2025-11-09 | Warnings | M020 |
| GoodSense SPF 30 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6% | Geiss, Destin, & Dunn, Inc. | c85c5d2b-35f6-2fd5-e053-2995a90a4a53 | 2025-11-09 | Warnings | M020 |
| Walgreens SPF 50 Tinted Mineral Fluid | TITANIUM DIOXIDE | Walgreens | 345918e3-95f8-404c-e063-6394a90a3fca | 2025-11-09 | Warnings | M020 |
| Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 Sunscreen | AVOBENZONE, OXYBENZONE, OCTISALATE, OCTINOXATE | Distribuidora Comercial Jafra, S.A. de C.V. | ad6646c7-c6aa-4610-a0c7-ddd1ddd13cde | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 500 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | d690d5d1-e1fa-404f-a17e-7b97be17b44a | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 510 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 2fbdeff7-4880-49ef-bb4d-e033d18e0459 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 540 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 6a86e5fd-6736-45e0-aa7d-d268fdaed4f8 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 560 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 42a3625f-5c58-4ec5-895f-b14f74428271 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 415 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 8e14fe81-cf7f-4a81-afec-e6c8466179c9 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 425 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 7dd9f4cb-78d8-4edc-a63c-d4a02930a0f8 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 450 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 8acb660f-94bd-4c4f-b0c1-3682cf8ed543 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC SPF 30 Fair 150 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | fad2bec7-c5f4-45f4-aff4-a5022033cb6a | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC SPF 30 Medium 355 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 39856c69-84fb-4b12-a713-8912263e42b1 | 2025-11-07 | Warnings | M020 |
| e l f Holy Hydration Face SPF 30 Sunscreen, | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc | 44a8028b-731d-4561-b2e3-ee9738ad8d30 | 2025-11-07 | Warnings | M020 |
| e l f Sun Boss Gloss SPF 25 Sunscreen Its your Mauve | ZINC OXIDE | e.l.f. Cosmetics, Inc. | bce21361-c92c-40ad-a373-db3b83b15b8a | 2025-11-07 | Warnings | M020 |
| e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Bronze Shimmer Sunburst | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc | 49d912c7-259a-487d-a523-b14031bfaab6 | 2025-11-07 | Warnings | M020 |
| e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Champagne Shimmer Sunlight | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 1e9bdd41-69c3-4034-bd9e-b4bc5a1bd50d | 2025-11-07 | Warnings | M020 |
| e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Peach Shimmer Sunbeam | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | f818f524-0263-4f89-b4f3-4dd83d688e7e | 2025-11-07 | 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 |