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 | 2026-11-13 | ||
| unfinished package | package | 37945-862 | 37945-862-10 | UNFINISHED | Active or certified unfinished drug listing | 2026-11-13 | |
| unfinished package | package | 37945-862 | 37945-862-20 | UNFINISHED | Active or certified unfinished drug listing | 2026-11-13 |
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 |
|---|---|---|---|---|---|---|
| Tenacious Ergodyne | SPF 50 SUNSCREEN LOTION | Tenacious Holdings, Inc. | aaaa1f54-1136-4062-85ba-0926351580bb | 2024-10-23 | Warnings | M020 |
| Bull Frog SPF 50 Quik with Water Armor Tech | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BULLFROG BRANDS, LLC. | f706f90c-eb79-2201-e053-6394a90a2ce4 | 2024-10-23 | Warnings | M020 |
| Bull Frog SPF 50 Quik with Water Armor Tech | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BULLFROG BRANDS, LLC. | f70816a3-cc04-b000-e053-6294a90a0fae | 2024-10-23 | Warnings | M020 |
| Alumier MD Post Procedure Kit | TITANIUM DIOXIDE, ZINC OXIDE | Alumier Labs | 252859de-6676-5e07-e063-6394a90a64a1 | 2024-10-23 | Warnings | M020 |
| Equate Sunscreen Tanning Oil With Coconut Oil SPF 6 | AVOBENZONE, HOMOSALATE | WAL-MART STORES INC. | f44d83d3-ffca-7a93-e053-2a95a90a7715 | 2024-10-23 | Warnings | M020 |
| Tanning Sunscreen UVB Protection Dry Oil Equate | AVOBENZONE, HOMOSALATE, OCTISALATE | WAL-MART STORES INC. | acdf62f2-742e-5df9-e053-2a95a90a96c5 | 2024-10-23 | Warnings | M020 |
| WALMART EQUATE BEAUTY ULTRA LIGHT SUNSCREEN SPF 100 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | WAL-MART STORES INC. | c8d4feca-7bee-2413-e053-2a95a90a739c | 2024-10-23 | Warnings | M020 |
| Equate Sunscreen for All Skin Tones SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Wal-Mart Stores Inc | f410ffcc-ef0e-13c4-e053-2a95a90a568a | 2024-10-23 | Warnings | M020 |
| Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44N | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Rare Beauty, LLC | cffbb6af-5a04-f58a-e053-2995a90a1ae2 | 2024-10-23 | Warnings | M020 |
| Banana Boat | TITANIUM DIOXIDE, ZINC OXIDE | Edgewell Personal Care Brands, LLC | 441a46f0-ecda-4448-e054-00144ff88e88 | 2024-10-23 | Warnings | M020 |
| Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28C | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Rare Beauty, LLC | cffb8219-7076-de64-e053-2a95a90a6036 | 2024-10-23 | Warnings | M020 |
| Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10N | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Rare Beauty, LLC | cfee02eb-92f9-be12-e053-2a95a90a4337 | 2024-10-23 | Warnings | M020 |
| CVS Pharmacy Kids SPF 70 Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS Pharmacy | 4eb824a6-66ac-01f8-e054-00144ff8d46c | 2024-10-22 | Warnings | M020 |
| CVS Health 60 Plus Sensitive Skin Sun | TITANIUM DIOXIDE, ZINC OXIDE | CVS Pharmacy | 477c25ec-33db-04a6-e054-00144ff8d46c | 2024-10-22 | Warnings | M020 |
| CVS Health SPF 70 Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS Pharmacy | 4eb75945-9d65-55b4-e054-00144ff88e88 | 2024-10-22 | Warnings | M020 |
| CVS Health Sport SPF 50 Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, | CVS Pharmacy | 4ec6384a-8faf-5712-e054-00144ff8d46c | 2024-10-22 | Warnings | M020 |
| CVS Health Sport SPF 30 Clear | AVOBENZONE, HOMOSALATE, OCTOCRYLENE, | CVS Pharmacy | 4ec6b50b-5236-6f5b-e054-00144ff8d46c | 2024-10-22 | Warnings | M020 |
| CVS Pharmacy SPF 70 Beach Guard Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS Pharmacy | 4ec75d23-a33b-6c52-e054-00144ff88e88 | 2024-10-22 | Warnings | M020 |
| CVS Health SPF 70 Beach Guard Sun | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS Pharmacy | 4adbd66a-6b38-046d-e054-00144ff8d46c | 2024-10-22 | Warnings | M020 |
| CVS Health Sport SPF 100 Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS Pharmacy | 651c245c-2d3a-0019-e053-2991aa0a4637 | 2024-10-22 | 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 |