PRVWORA Ultra Defense Sunscreen
- Product NDC
- 87482-001
- 11-digit product format
- 874820001
- Labeler code
- 87482
- Product ID
- 87482-001_4e9f781d-6b07-b69a-e063-6394a90a36c8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Octinoxate, Octisalate, Octocrylene
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Cellarkbio Inc.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-04-04
- Substance
- OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE
- Active strength
- 72.5; 45; 95; 28.5 mg/mL; 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
- PRVWORA Ultra Defense Sunscreen
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTINOXATE | 72.5 mg/mL |
| OCTISALATE | 45 mg/mL |
| OCTOCRYLENE | 95 mg/mL |
| AVOBENZONE | 28.5 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4Y5P7MUD51 | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
| 5A68WGF6WM | Internal UNII lookup |
| G63QQF2NOX | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 50cf1d88-3e7e-47b7-816a-3d579bde0a6a | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 8234c772-5c41-424c-a33e-e06e8c4de9c1 | Product name | 2 | 20250626 |
| fbe2ea47-480e-f5f1-0d64-c87fd5ac923b | Product name | 4 | 20250224 |
| 510b43a3-8143-a25f-19c6-476c90dbb618 | Product name | 9 | 20171115 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 87482-001-01 | PRVWORA Ultra Defense Sunscreen | 50 mL in 1 TUBE | CREAM | 50 | 1 | |
| 87482-001-02 | PRVWORA Ultra Defense Sunscreen | 1 in 1 CARTON | CREAM | 1 | 1 |
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 |
|---|---|---|---|---|---|---|
| Eclipse Face Tinted | ZINC OXIDE | DENISE BELL SKIN CARE | 396f0151-2d0d-f4da-e063-6394a90a5f7f | 2025-12-15 | M020 | |
| Eclipse Body Non Tinted | ZINC OXIDE | DENISE BELL SKIN CARE | 396f56df-d0de-1344-e063-6294a90a46ea | 2025-12-15 | M020 | |
| Solar Shield Tinted | TITANIUM DIOXIDE, ZINC OXIDE | DENISE BELL SKIN CARE | 396eb781-5947-3665-e063-6294a90a38dd | 2025-12-15 | M020 | |
| Sun Veil Illuminating Sunscreen SPF30 | ZINC OXIDE | Koco Life LLC | 46001097-540e-65da-e063-6294a90af299 | 2025-12-15 | Warnings | M020 |
| Mineral Primer tinted SPF40 | TITANIUM DIOXIDE, ZINC OXIDE | Oracle Esthetics, LLC | 3542d8d3-35a3-7d63-e063-6394a90a6fd1 | 2025-12-15 | M020 | |
| Mineral Primer non-tinted SPF40 | TITANIUM DIOXIDE, ZINC OXIDE | Oracle Esthetics, LLC | 354357de-1a85-3bdb-e063-6294a90aa9a2 | 2025-12-15 | M020 | |
| Mineral Primer tinted SPF40 | TITANIUM DIOXIDE, ZINC OXIDE | Oracle Esthetics, LLC | 35433254-1dc8-a8f3-e063-6394a90a29f0 | 2025-12-15 | M020 | |
| Sun Therapy Sunscreen | ZINC OXIDE | Skin Therapy Studio LLC | 3544916b-3f63-3a7a-e063-6394a90ae507 | 2025-12-15 | M020 | |
| Ultra Zinc Mineral Non Tinted | ZINC OXIDE | Skin Therapy Studio LLC | 3545d603-3d01-c51d-e063-6394a90a1599 | 2025-12-15 | M020 | |
| Sun Therapy Sunscreen | ZINC OXIDE | Skin Therapy Studio LLC | 357efafb-aa1c-0d69-e063-6394a90a5135 | 2025-12-15 | M020 | |
| Ultra Zinc Mineral Non Tinted | ZINC OXIDE | Skin Therapy Studio LLC | 35806102-6919-116f-e063-6294a90ad922 | 2025-12-15 | M020 | |
| Complexion Correction Primer Sunscreen clear | TITANIUM DIOXIDE, ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 357eee3c-1c21-5efb-e063-6294a90a4bb7 | 2025-12-15 | M020 | |
| Complexion Correction Tinted Primer Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 357e75ec-473e-df76-e063-6294a90a70c7 | 2025-12-15 | M020 | |
| Complexion Correction Tinted Primer Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 357f2f62-904a-2234-e063-6394a90aee72 | 2025-12-15 | M020 | |
| Superscreen Daytime Mineral Sunscreen | ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 357f915a-bd77-350b-e063-6294a90ad27f | 2025-12-15 | M020 | |
| Complexion Correction Primer Sunscreen clear | TITANIUM DIOXIDE, ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 357ff025-84ad-6d77-e063-6394a90aad95 | 2025-12-15 | M020 | |
| Complexion Correction Tinted Primer Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 358021a2-235b-825b-e063-6394a90a76f5 | 2025-12-15 | M020 | |
| Superscreen Daytime Mineral Sunscreen | ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 35805e66-18e6-0e45-e063-6294a90afe58 | 2025-12-15 | M020 | |
| Ultra Zinc Physical Defense | ZINC OXIDE | ATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER | 35474ac4-8a9d-6a84-e063-6394a90a9bad | 2025-12-15 | M020 | |
| Ultra Zinc Physical Defense | ZINC OXIDE | ATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER | 357e315e-8802-ad73-e063-6394a90a2495 | 2025-12-15 | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 87482-001-01 | 87482000101 | 50 mL in 1 TUBE | 50 ml | Historical | |||
| 87482-001-02 | 87482000102 | 1 TUBE in 1 CARTON (87482-001-02) / 50 mL in 1 TUBE (87482-001-01) | 1 tube | 2026-04-04 | No | No | Current |