Essential Mineral Sun Protection
- Product NDC
- 85387-258
- 11-digit product format
- 853870258
- Labeler code
- 85387
- Product ID
- 85387-258_45b370ec-f575-b104-e063-6294a90a105b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Fern Burg
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-06-13
- Substance
- TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 100; 30 mg/g; mg/g
- 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
- Essential Mineral Sun Protection
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TITANIUM DIOXIDE | 100 mg/g |
| ZINC OXIDE | 30 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 15FIX9V2JP | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 34a360b2-6798-c7e8-e063-6294a90a5cbb | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85387-258-50 | Essential Mineral Sun Protection | 53 g in 1 BOTTLE, PUMP | CREAM | 53 | 2 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| PRO-TECT SUNSCREEN FOR PROFESSIONALS | MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE | Bio-Medical & Pharmaceutical Manufacturing Corporation | 374e172b-90e8-4fca-8934-dee3ed7b599d | 2025-12-03 | Warnings | M020 |
| LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 BERRY UNIVERSEL | OCTINOXATE, ZINC OXIDE | BEL STAR S A | 25b6cb46-6516-376a-e063-6394a90a44f6 | 2025-12-03 | Warnings | M020 |
| LBEL LUMI AGE ANTI AGING NOURISHING FACIAL WITH SPF 30 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | BEL STAR SA | 4510cd0d-40b8-f452-e063-6394a90a44e5 | 2025-12-03 | Warnings | M020 |
| BANANA BOAT | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 45117885-c674-b58a-e063-6394a90af5f4 | 2025-12-03 | Warnings | M020 |
| CANNON BALM | OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE | DUKE CANNON SUPPLY CO. | f70a0173-c8ba-da7c-e053-6294a90a67db | 2025-12-03 | Warnings | M020 |
| CANNON BALM 140 | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | DUKE CANNON SUPPLY CO. | f70c8632-ed11-0cc3-e053-6394a90a77db | 2025-12-03 | Warnings | M020 |
| Omega-Boost Sheer Mineral Sunscreen | MINERAL SUNSCREEN | Trilogy Natural Products Limited | 0405b7a6-6885-ed93-e063-6294a90a9386 | 2025-12-03 | Warnings | M020 |
| Poolside Hot Head SPF 30 hair scalp sunscreen mist | HOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 4517da75-c91a-1f93-e063-6394a90a65ac | 2025-12-03 | Warnings | M020 |
| Poolside Tropic Touch SPF 30 Sunscreen Body spray. | HOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 4517ef95-8ea1-3de6-e063-6394a90a2c79 | 2025-12-03 | Warnings | M020 |
| Poolside Orange Creme SPF 30 Sunscreen oil mist | HOMOSALATE 15%, OCTOCRYLENE 10%, OCTISALATE 5%, AVOBENZONE 3% | Longway Technology(Guangzhou)Co.,Ltd. | 4517fd05-ea60-0492-e063-6294a90a28e9 | 2025-12-03 | Warnings | M020 |
| e.l.f. All Set For Sun SPF 45 Sunscreen | AVOBENZONE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 26f43446-e5ee-57a5-e063-6394a90a8661 | 2025-12-03 | Warnings | M020 |
| Banana Boat | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | Edgewell Personal Care Brands LLC | 7678467a-9da3-1b51-e053-2991aa0a568f | 2025-12-02 | Warnings | M020 |
| Cardinal Health Leader General Protection SPF 70 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE | CARDINAL HEALTH, INC. | b60cf360-7c8d-5da4-e053-2995a90a24c2 | 2025-12-02 | Warnings | M020 |
| Cardinal Health Leader General Protection Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH, INC. | b6107d22-a992-eaa1-e053-2995a90a29c2 | 2025-12-02 | Warnings | M020 |
| Cardinal Health Leader General Protection Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH, INC. | b623defb-4a9d-6fc5-e053-2995a90ae846 | 2025-12-02 | Warnings | M020 |
| Cardinal Health Leader Sport Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH, INC. | b62329d7-29e9-d111-e053-2a95a90aab06 | 2025-12-02 | Warnings | M020 |
| Leader Ultra Sheer SPF 100 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CARDINAL HEALTH, INC. | b5a467e0-a6ab-4136-8101-f22cc319de58 | 2025-12-02 | Warnings | M020 |
| Leader General Protection SPF 30 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH, INC. | 9544b046-055e-5886-e053-2a95a90ad09e | 2025-12-02 | Warnings | M020 |
| BANANA BOAT | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 44fe0844-cb74-7a04-e063-6294a90aca15 | 2025-12-02 | Warnings | M020 |
| CLINIQUE FOR MEN DAILY HYDRATOR BROAD SPECTRUM SPF 35 | AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENE | CLINIQUE LABORATORIES LLC | 44fe7468-001c-f2ee-e063-6394a90ae3b4 | 2025-12-02 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85387-258-50 | 85387025850 | 53 g in 1 BOTTLE, PUMP (85387-258-50) | 53 g | 2023-06-13 | No | No | Current |