PRO-TECT SPORTS SUNSCREEN
- Product NDC
- 37945-862
- 11-digit product format
- 379450862
- Labeler code
- 37945
- Product ID
- 37945-862_450fc7aa-e2e3-c6ff-e063-6394a90a1035
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Meradimate, Octinoxate, Octisalate, Oxybenzone
- Dosage form
- LOTION
- Route
- CUTANEOUS
- Labeler
- Bio-Medical & Pharmaceutical Manufacturing Corporation
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-05-27
- Substance
- OCTINOXATE; MERADIMATE; OXYBENZONE; OCTISALATE
- Active strength
- 75; 50; 30; 50 mg/g; mg/g; mg/g; mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| unfinished product | product | 37945-862 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-16 | ||
| unfinished package | package | 37945-862 | 37945-862-10 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-16 | |
| unfinished package | package | 37945-862 | 37945-862-20 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-16 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 37945-862-10 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 37945-862-20 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 1d862106b807… | 00c93037cd84… | |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 37945-862-10 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 37945-862-20 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 37945-862-10 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 37945-862-20 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | e30019b0c005… | a3f0b14938b7… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 37945-862-10 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 37945-862-20 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 37945-862-10 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 37945-862-20 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 37945-862-10 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 37945-862-20 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | f764e8902f78… | 92046438deef… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 37945-862-10 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | f764e8902f78… | 92046438deef… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 37945-862-20 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 37945-862-10 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 68b1e3bced9e… | 98a755eb8bc6… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 37945-862-20 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 37945-862-10 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 37945-862-20 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 48b4f40e6753… | c7c7a00d2afa… | |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 37945-862-10 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 37945-862-20 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 27f29a85d7e4… | 1372111e901f… | |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 37945-862-10 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 27f29a85d7e4… | 1372111e901f… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 37945-862-20 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 27f29a85d7e4… | 1372111e901f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 8d62ce987f31… | 9fe9ef23e30d… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 37945-862-10 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 37945-862-20 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | d1e113ab4d42… | 063ee3eb0a1d… | |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 37945-862-10 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 37945-862-20 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished product | product | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 50b4072663b7… | eae3003ed65e… | |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 37945-862-10 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 50b4072663b7… | eae3003ed65e… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 37945-862-20 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 50b4072663b7… | eae3003ed65e… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 37945-862-64 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 37945-862-65 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… |
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
- PRO-TECT SPORTS SUNSCREEN
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTINOXATE | 75 mg/g |
| MERADIMATE | 50 mg/g |
| OXYBENZONE | 30 mg/g |
| OCTISALATE | 50 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4Y5P7MUD51 | Internal UNII lookup |
| J9QGD60OUZ | Internal UNII lookup |
| 95OOS7VE0Y | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 16994959-cade-06de-e054-00144ff88e88 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37945-862-65 | PRO-TECT SPORTS SUNSCREEN | 190 g in 1 CONTAINER | LOTION | 190 | 25 | |
| 37945-862-64 | PRO-TECT SPORTS SUNSCREEN | 100 g in 1 BOTTLE | LOTION | 100 | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 37945-862 | PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION] | 24 | Current NDC, Legacy NDC, 1 package rows | 20241004_66bb06fb-33d2-4b57-a65f-66bcd187c627.zip |
| 37945-862 | PRO-TECT SPORTS SUNSCREEN (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION] | 5 | Current NDC, Legacy NDC, 1 package rows | 20231216_16994959-cade-06de-e054-00144ff88e88.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 |
|---|---|---|---|---|---|---|
| Avebonzone, Homosalate, Octisalate | AVEBONZONE, HOMOSALATE, OCTISALATE | Amazon.com Services LLC | 4ab66c16-5f4c-6987-e063-6294a90add86 | 2026-02-26 | Warnings, Adverse reactions | M020 |
| Seonglow Daily Moisturizing Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | SeonGlow Inc. | 01f3479f-3a0d-420b-bbf8-62a0a225bc9b | 2026-02-26 | Warnings | M020 |
| Avebonzone, Homosalate, Octisalate | AVEBONZONE, HOMOSALATE, OCTISALATE | Amazon.com Services LLC | 4ab5d5ca-26bf-1c5f-e063-6394a90a00ca | 2026-02-26 | Warnings, Adverse reactions | M020 |
| SPF50 Moisturizer with Aloe, Green Tea and Shea Butter | ZINC OXIDE | Audrey Morris Cosmetics International, LLC | 92960e14-9845-49aa-b3ce-c8023aa109b6 | 2026-02-26 | Warnings | M020 |
| Naturalessa SPF50 Moisturizer | ZINC OXIDE | Audrey Morris Cosmetics International, LLC | 816ddfa1-cb55-4591-a90b-71631cb17626 | 2026-02-26 | Warnings | M020 |
| UV DEFENSE FACE MINERAL SPF 50 | ZINC OXIDE | BETTER INVENTION LTD | 4b9a9efe-9aba-0ed0-e063-6394a90a2c6b | 2026-02-26 | Warnings | M020 |
| MISTINE UV DEFENSE FACE SUNSCREEN SPF50 | AVOBENZONE, HOMOSOLATE, OCTISALATE, OCTOCRYLENE | BETTER INVENTION LTD | 4b9a8f28-9043-8fb7-e063-6294a90a34d3 | 2026-02-26 | Warnings | M020 |
| MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BETTER INVENTION LTD | 4b9a8f28-9041-8fb7-e063-6294a90a34d3 | 2026-02-26 | Warnings | M020 |
| Rationale The Discovery Travel Kit | ZINC OXIDE | RATIONALE GROUP PTY LTD | 0c919aea-4bd4-427e-97e7-9c153b42f491 | 2026-02-25 | Warnings | M020 |
| Kiss My Face Purely Mineral Daily 50 Sunscreen SPF 50 | ZINC OXIDE | Windmill Health Products, LLC | ebfb149c-0371-4492-b03a-5fdcb7821753 | 2026-02-25 | Warnings | M020 |
| SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORY | OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | c05cef12-a6a7-4682-9357-6d77f4ca3267 | 2026-02-25 | Warnings | M020 |
| cle de peau BEAUTE Protective Day | AVOBENZONE, OCTINOXATE, OCTOCRYLENE | Shiseido Americas Corporation | dea8e4c1-6a9c-44c6-abc8-6cdd50f35f49 | 2026-02-25 | Warnings | M020 |
| Aura Defense | ZINC OXIDE | Grace and Glow MD LLC | 4ba75eff-74ef-278b-e063-6394a90a8ef0 | 2026-02-25 | Warnings | M020 |
| AM Shield plus | ZINC OXIDE | Grace and Glow MD LLC | 4ba7c282-c68e-8719-e063-6394a90a3814 | 2026-02-25 | Warnings | M020 |
| cle de peau BEAUTE RADIANT FOUNDATION N M I10 | OCTINOXATE AND TITANIUM DIOXIDE | Shiseido Americas Corporation | 3be1fe06-bd3b-4078-bee9-d3caf8d068ff | 2026-02-25 | Warnings | M020 |
| Jack Black | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 4babe2ab-c5da-9a83-e063-6294a90aee4c | 2026-02-25 | Warnings | M020 |
| Daily Facial Moisturizer SPF 25 | SUNSCREEN | Person and Covey | 6b9258e4-c7c6-765e-e053-2991aa0a9f4e | 2026-02-25 | Warnings | M020 |
| Jack Black | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 4bac1c33-36fe-8d29-e063-6394a90a32a5 | 2026-02-25 | Warnings | M020 |
| Jack Black | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 4bac5550-c45f-a738-e063-6394a90ae5c8 | 2026-02-25 | Warnings | M020 |
| Jack Black | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 4baca374-7aaa-8d1d-e063-6394a90a5a55 | 2026-02-25 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 37945-862-10 | 37945086210 | 185973 g in 1 DRUM (37945-862-10) | 185973 g | 26-MAY-22 | Current | |||
| 37945-862-20 | 37945086220 | 18144 g in 1 PAIL (37945-862-20) | 18144 g | 12-MAY-23 | Current | |||
| 37945-862-64 | 37945086264 | 100 g in 1 BOTTLE (37945-862-64) | 100 g | 2015-05-27 | 0000-00-00 | No | No | Current |
| 37945-862-65 | 37945086265 | 190 g in 1 CONTAINER (37945-862-65) | 190 g | 2015-02-05 | 0000-00-00 | No | No | Current |