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 |
|---|---|---|---|---|---|---|
| Stream2Sea Broad Spectrum 20 | TITANIUM DIOXIDE | Stream2Sea, LLC | 1775d07d-6914-6928-e054-00144ff88e88 | 2025-11-06 | Warnings | M020 |
| PHYSICAL TINTED MOISTURIZER SPF44 | ZINC OXIDE, TITANIUM DIOXIDE | Drmtlgy, LLC | 483d0d28-56f3-4b37-af03-0331e1653d73 | 2025-11-06 | Warnings | M020 |
| Neutrogena Rapid Wrinkle Repair Retinol Moisturizer Sunscreen Broad Spectrum SPF 30 Day | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Kenvue Brands LLC | d3ebe2a9-434e-497c-8fed-b5c73c70a58b | 2025-11-05 | Warnings | M020 |
| Clear Smart Shine Control Sunscreen Broad Spectrum SPF 25 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Distribuidora Comercial Jafra, S.A. de C.V. | a57bcf44-580d-520e-e053-2a95a90a6923 | 2025-11-05 | Warnings | M020 |
| Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Distribuidora Comercial Jafra, S.A. de C.V. | 865057ce-f617-4232-a60e-e23c120b0a73 | 2025-11-05 | Warnings | M020 |
| Revitalize Solar Protection Fluid Broad Spectrum SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Distribuidora Comercial Jafra, S.A. de C.V. | 29b3ee35-e849-4427-a455-37d92c4b995c | 2025-11-05 | Warnings | M020 |
| Sarah Creal Brilliant Repair Shield | ZINC OXIDE | Sarah Creal LLC | 258ab6f2-f1a7-2d0d-e063-6294a90af34a | 2025-11-05 | Warnings | M020 |
| Perricone MD Cold Plasma Plus Neck and Chest Broad Spectrum SPF 25 | TITANIUM DIOXIDE | THG Beauty USA LLC | 23a55301-2277-6e4f-e063-6394a90af171 | 2025-11-05 | Warnings | M020 |
| Sun Bum Face and Body Stick 40 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Sun Bum, LLC | 20d9d60d-e0ce-a177-e063-6394a90a162e | 2025-11-05 | Warnings | M020 |
| Obagi Nu-Derm Fx System Normal-Dry Skin Transformation Complexion Brightening System | TITANIUM DIOXIDE, ZINC OXIDE | Obagi Cosmeceuticals LLC | 4cbf1dc6-78b3-4e51-a53f-2018ac88136a | 2025-11-04 | Warnings | M020 |
| SUNBEAT PROCARE FPS 50 KIDS | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, ENSULIZOLE | Tecnoglobal, PH7 S.A. DE C.V. | 42c74ddf-70a3-f2b1-e063-6294a90a91a9 | 2025-11-04 | Warnings | M020 |
| Vertra Pearl White Face Stick SPF 50 | PADIMATE O, TITANIUM DIOXIDE | Toshiki Pigment Co., ltd. | b7163861-7084-5adf-e053-2995a90ae199 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 8 | OCTINOXATE AND OXYBENZONE | Tropical Seas, Inc. | b5fa2883-998f-2128-e053-2995a90a5c84 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 15 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b557c9c5-6ea8-1d59-e053-2995a90aff68 | 2025-11-04 | Warnings | M020 |
| Vertra Ehukai Beige Face Stick SPF 38 | TITANIUM DIOXIDE | Toshiki Pigment Co., ltd. | b71619c4-a8ef-1dda-e053-2995a90aba50 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 45 | OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE | Tropical Seas, Inc. | b4cafdf1-44e1-10c0-e053-2995a90ab3dc | 2025-11-04 | Warnings | M020 |
| Reef Kids SPF 30 Oxybenzone Free | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | e226b07a-9f44-4b17-8f26-c86dcfa5dcda | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 50 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b4cc95f0-d684-5331-e053-2995a90a3295 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 20 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b55792e6-2ead-1fb1-e053-2995a90ac915 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 8 | OCTINOXATE AND OXYBENZONE | Tropical Seas, Inc. | b5e68448-4131-1c6c-e053-2a95a90a014a | 2025-11-04 | 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 |