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 |
|---|---|---|---|---|---|---|
| Land Shark SPF 30 Tinted Zinc | ZINC OXIDE AND TITANIUM DIOXIDE | Tropical Seas, Inc. | d1287899-f178-6124-e053-2a95a90a95a5 | 2025-11-04 | Warnings | M020 |
| Naked Sundays BeautyScreen Peptide Foundation Tint | ZINC OXIDE | Naked Sundays | 1a623dfc-a8fc-858b-e063-6294a90a9c11 | 2025-11-04 | Warnings | M020 |
| Odacite Mineral Drops Sheer Sunscreen | ZINC OXIDE | Odacite | 303f3af6-631a-57a8-e063-6294a90addda | 2025-11-04 | Warnings | M020 |
| Medline | ZINC OXIDE | Medline Industries, LP | cadba3bc-4a06-872a-e053-2995a90ab447 | 2025-11-04 | Warnings | M020 |
| Perricone MD Hypoallergenic CBD Sensitive Skin Therapy Ultra-Lightweight Calming SPF 35 Veil | ZINC OXIDE | THG Beauty USA LLC | 2392c772-c251-1597-e063-6394a90a52f2 | 2025-11-03 | Warnings | M020 |
| Hawaiian Tropic everyday Active Sport Sunscreen SPF50 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care LLC | dc7d0757-c8a2-7fdb-e053-2a95a90a5282 | 2025-11-03 | Warnings | M020 |
| MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant (80min) Mineral Sunscreen LIGHT | TITANIUM DIOXIDE AND ZINC OXIDE | MDSolarSciences | a7f906f6-3041-4c24-955d-90cdd402dd02 | 2025-11-03 | Warnings | M020 |
| Biopo Facial Mineral Sunscreen-Non Tinted SPF 40 | BIOPO FACIAL MINERAL SUNSCREEN-NON TINTED SPF 40 | Guangzhou Ariel Biotech Co., Ltd. | 42bc865f-29bd-da90-e063-6294a90aa16d | 2025-11-03 | Warnings | M020 |
| Biopo Facial Mineral Sunscreen- Tinted SPF 40 | BIOPO FACIAL MINERAL SUNSCREEN- TINTED SPF 40 | Guangzhou Ariel Biotech Co., Ltd. | 42bd8bce-2959-266a-e063-6394a90a9a41 | 2025-11-03 | Warnings | M020 |
| GoodSense SPF 30 Sunscreen | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10% | Geiss, Destin, & Dunn, Inc. | c23c754a-9441-0a05-e053-2995a90afc55 | 2025-11-02 | Warnings | M020 |
| SPF 30 Sport Sunscreen GoodSense | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8% | Geiss, Destin, & Dunn, Inc | a22c6359-435d-626b-e053-2a95a90ae0c6 | 2025-11-02 | Warnings | M020 |
| Iris and Romeo Weekend Skin | ZINC OXIDE | Iris and Romeo | 0828a345-0178-1503-e063-6394a90a7d24 | 2025-10-31 | Warnings | M020 |
| Iris and Romeo Weekend Skin Bronze Glow | ZINC OXIDE | Iris and Romeo | 2abe1780-d1e6-a90a-e063-6294a90a64ee | 2025-10-31 | Warnings | M020 |
| Iris and Romeo Weekend Skin Warm Glow | ZINC OXIDE | Iris and Romeo | 0852977a-83e5-26cf-e063-6294a90ab3f9 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Light 205 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 055878ef-c671-4d65-9639-bda5a1dc3029 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Fair 120 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | b6b18a13-1f22-4061-91f5-852f7a487c03 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Fair 100 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | d7815651-6b14-41f6-90cd-0a5b0b4a12ac | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Fair 140 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 59331429-5fe0-4671-aabd-ec20640dd3ee | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Fair 125 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | c6ef3b07-babf-401d-a241-4e81e162c965 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Medium 330 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | c6d4b851-bf09-4177-b473-a2378c55ceec | 2025-10-31 | 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 |