Homosalate, Octisalate, Zinc oxide
- Product NDC
- 76162-957
- 11-digit product format
- 761620957
- Labeler code
- 76162
- Product ID
- 76162-957_4ab9f7f0-adbb-d8a3-e063-6394a90ad8d0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Homosalate, Octisalate, Zinc oxide
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Topco Associates LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-01-22
- Substance
- HOMOSALATE; ZINC OXIDE; OCTISALATE
- Active strength
- 100; 63; 50 mg/mL; mg/mL; mg/mL
- 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
- Homosalate, Octisalate, Zinc oxide
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HOMOSALATE | 100 mg/mL |
| ZINC OXIDE | 63 mg/mL |
| OCTISALATE | 50 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V06SV4M95S | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 48fb9a3c-c058-ce71-e063-6294a90aaf1e | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76162-957-21 | Homosalate, Octisalate, Zinc oxide | 89 mL in 1 BOTTLE, PLASTIC | LOTION | 89 | 2 | |
| 76162-957-21 | Homosalate, Octisalate, Zinc oxide | 1 in 1 CARTON | LOTION | 1 | 2 |
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 |
|---|---|---|---|---|---|---|
| GR SATIN SMOOTHING Fluid Foundation SPF 15 | OCTINOXATE, OXYBENZONE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 1eba51f2-782e-480e-8555-f5ad8883fa0d | 2025-08-06 | Warnings | M020 |
| GR TOTAL COVER 2 in 1 Foundation and Concealer SPF 15 | OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 038ec45a-0d56-4cd9-8060-767b382c1237 | 2025-08-06 | Warnings | M020 |
| GR CC Broad Spectrum SPF 30 | OCTINOXATE, OXYBENZONE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 751d5194-f5ea-401b-9439-7770510a588c | 2025-08-06 | Warnings | M020 |
| GR NUDE LOOK SPF 25 | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 96dae912-8fa5-4d0e-b873-e1dbb7398db0 | 2025-08-06 | Warnings | M020 |
| GR BB SPF 25 | OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 3b22579b-21ce-4b96-bd24-774ce35bf6f7 | 2025-08-06 | Warnings | M020 |
| Neutrogena Ultra Sheer Invisible Gel Face Sunscreen SPF 40 Broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Kenvue Brands LLC | 3b9a4bd9-cbe1-60c5-e063-6394a90a5892 | 2025-08-05 | Warnings | M020 |
| Neutrogena Hydro Boost City Shield water Broad Spectrum SPF 25 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Kenvue Brands LLC | 77e4bbcc-0a51-4e9c-9328-46bcbf4f8129 | 2025-08-05 | Warnings | M020 |
| Aveeno Positively Radiant Daily Moisturizer Sunscreen Broad Spectrum SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Kenvue Brands LLC | decb4842-c880-0668-e053-2995a90aad7e | 2025-08-05 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 08W Light | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 498bf941-67f2-41d5-a039-9f827b68297e | 2025-08-05 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 10N Light Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 54e390bd-b84a-4c43-986e-74923e34689d | 2025-08-05 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 09C Light Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 897024cd-576e-4a8e-8daa-92dc3bb4b3a5 | 2025-08-05 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 11W Light Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 303967d1-9df8-4a8e-a264-6b0d8fdbf2a8 | 2025-08-05 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 12N Light Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 26062cd7-3817-46c7-b65f-92cd57eca5dd | 2025-08-05 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 13C Light Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 448a24a3-91ef-4530-828c-e77d8aae7f0b | 2025-08-05 | Warnings | M020 |
| JORDAN FAT KIDS Tallow Sunscreen SPF 30 | MENTHOL, METHYL SALICYLATE | JORDAN FAT KIDS LLC | 72ac88cf-9f20-44ea-b3a2-12c922eec2b3 | 2025-08-04 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 02C Light | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 09f9e59b-6f71-4d42-9b5d-275f756d985b | 2025-08-04 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 03W Light | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 3b1e4480-8409-425e-b98d-eb4dcf2471e8 | 2025-08-04 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 06W Light | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 3090422e-fc18-45b8-88f2-6a9b282a7205 | 2025-08-04 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 05N Light | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | f93aa5d2-90ab-4e11-874e-2ede4b25c4b6 | 2025-08-04 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 04C Light | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | f055cd51-7b1d-43df-8990-8f60ba1eb91c | 2025-08-04 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 76162-957-21 | 76162095721 | 1 BOTTLE, PLASTIC in 1 CARTON (76162-957-21) / 89 mL in 1 BOTTLE, PLASTIC | 2026-01-22 | No | No | Current |