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 |
|---|---|---|---|---|---|---|
| e l f Camo Semi Matte CC SPF 30 Light 210 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 2f151e6c-ab2d-40cb-a67c-e067147ed702 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Light 280 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 6b0b9204-f205-415b-bd16-1970958b8be7 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Light 240 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 8c12a34c-f648-4b55-8265-d430c72ae205 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Light 250 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 0b1c20e6-9d98-4b69-8fe0-ac5e9f2b9b2c | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Medium 370 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | b8d4862e-2671-4b85-8338-f935e0d0194f | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Medium 310 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 8d53abee-73bc-4268-b08d-0c196ff4d852 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Medium 375 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 1de296f5-276b-4e8f-8db2-78ea01965c4a | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Rich 610 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 75543b93-8ed9-4c7b-9fcf-99745df5a194 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Rich 620 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 798eecb3-ff6e-46d1-9053-b40e9cd02e5c | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Rich 640 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | cbf949b3-e640-48eb-acf6-fccd6f258865 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Rich 650 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | b8bfad36-54b7-42f3-bb5b-5eda1a10f021 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Rich 660 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 853100ea-a9dc-43eb-9715-125b543d2be0 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Tan 400 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | e4f2b579-4886-4e20-a527-c033e9d60bf5 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Tan 460 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 49255019-fa24-4667-b527-ef7189a51f12 | 2025-10-31 | Warnings | M020 |
| SEKKISEI HERBAL UV DEFENSE gel | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | KOS America, Inc. | cb0faa3a-68f8-49c5-8c28-3338b1b27cd8 | 2025-10-31 | Warnings | M020 |
| Perricone MD Hypoallergenic Clean Correction Ultra-Lightweight Calming SPF 35 Veil | ZINC OXIDE | THG Beauty USA LLC | 2c749a52-adaa-2609-e063-6294a90a8fc2 | 2025-10-30 | Warnings | M020 |
| ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM | AVOBENZONE, HOMOSALATE, OCTISALATE | SEORIN COMPANY Co., Ltd. | 4260e410-d2d5-71b4-e063-6294a90a05b8 | 2025-10-30 | Warnings | M020 |
| Clove Hill Tinted Mineral Sunscreen SPF 40 | TITANIUM DIOXIDE, ZINC OXIDE | Clove Hill LLC | eb2ff5a7-384f-4379-b149-47c1c8c2291d | 2025-10-30 | Warnings | M020 |
| Tinted Mineral Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Clove Hill LLC | a37db64d-8b79-40f4-843f-f38949c5b9d2 | 2025-10-30 | Warnings | M020 |
| WEIGHTLESS PROTECTION SPF 30 | OCTINOXATE, ZINC OXIDE, OCTISALATE | Botanical Science Technologies | de9a97b8-6633-4d71-e053-2995a90a5e8f | 2025-10-30 | 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 |