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 |
|---|---|---|---|---|---|---|
| Brightening Primer SPF 20 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | a42d6761-47cd-4c9b-9656-64e37e065639 | 2025-12-17 | Warnings | M020 |
| Avail Body with Sunscreen | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Emeis Cosmetics Pty Ltd | 4bb39ea1-f948-4357-b425-0cafd454ce30 | 2025-12-17 | Warnings | M020 |
| Bronzing Primer SPF 20 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | f749af07-0fcd-4376-be62-7c078b3e7eb6 | 2025-12-17 | Warnings | M020 |
| Miffy Tone Perfecting SPF Cushion | HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE | RBGROUP Co., Ltd | 98a2906d-61e2-4627-a695-a20f10872f9a | 2025-12-16 | Warnings | M020 |
| Dear Sun Tone Perfecting SPF Cushion | HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE | RBGROUP Co., Ltd | 80748647-e0ea-46dc-8ee2-a0ad77c4b19d | 2025-12-16 | Warnings | M020 |
| SUNSCREEN Stick | ZINC OXIDE 15%, TITANIUM DIOXIDE 8%, HOMOSALATE 6% | Foshan Sugar Max Cosmetics CO.,Ltd | 460e1038-30f0-a6e4-e063-6394a90ad534 | 2025-12-16 | Warnings | M020 |
| SUNSCREEN SPRAY150ml | ZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4% | Foshan Sugar Max Cosmetics CO.,Ltd | 460ead6c-dd44-e320-e063-6294a90a2b64 | 2025-12-16 | Warnings | M020 |
| Sunscreen Cream | ZINC OXIDE 12%,TITANIUM DIOXIDE 8%, HOMOSALATE 12%, OCTISALATE4.5%,PHENYLBENZIMIDAZOLE SULFONIC ACID 3.5% | Foshan Sugar Max Cosmetics CO.,Ltd | 460f0ca0-9440-9a6e-e063-6394a90a33b3 | 2025-12-16 | Warnings | M020 |
| Unseen Sunscreen Lip Protector SPF 30 | OCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATE | Supergoop LLC | db12a89f-5fef-1b2a-e053-2a95a90a56f9 | 2025-12-16 | Warnings | M020 |
| Tinted Mineral Sunscreen | ZINC OXIDE | Natur LLC | 365f3c48-15a6-2d32-e063-6394a90aad78 | 2025-12-16 | M020 | |
| Non Tinted Mineral Sunscreen | ZINC OXIDE | Natur LLC | 365fffa2-b846-7dd3-e063-6394a90a47cb | 2025-12-16 | M020 | |
| Tinted Replenishing Daily Protection | ZINC OXIDE | Natur LLC | 36603550-9c3d-5e33-e063-6394a90adfc9 | 2025-12-16 | M020 | |
| Shield And Protect Tinted | ZINC OXIDE | TRILOGY LABORATORIES, LLC | 37f00e51-1123-c04c-e063-6294a90abed8 | 2025-12-16 | M020 | |
| Shield And Protect | ZINC OXIDE | TRILOGY LABORATORIES, LLC | 37f09dd5-084f-3c80-e063-6394a90a7a53 | 2025-12-16 | M020 | |
| Non Tinted Facial Mineral Protectant | TITANIUM DIOXIDE, ZINC OXIDE | EUROPEAN SKIN AND MASSAGE STUDIO | 3766496f-231c-f98c-e063-6294a90aae08 | 2025-12-16 | M020 | |
| Tinted Facial Mineral Protectant | TITANIUM DIOXIDE, ZINC OXIDE | EUROPEAN SKIN AND MASSAGE STUDIO | 3766b0d8-20e6-a227-e063-6294a90af4da | 2025-12-16 | M020 | |
| Non-Tinted Mineral Sunscreen | ZINC OXIDE | WECARE FRISCO PLLC | 37515807-e29a-3916-e063-6394a90a1ffd | 2025-12-16 | M020 | |
| Tinted Mineral Sunscreen Broad Spectrum SPF 40 | TITANIUM DIOXIDE, ZINC OXIDE | WECARE FRISCO PLLC | 374f866d-eb52-61e3-e063-6394a90a77c7 | 2025-12-16 | M020 | |
| Tinted Lip Protection | TITANIUM DIOXIDE, ZINC OXIDE | WECARE FRISCO PLLC | 3750c23d-c3f8-fac3-e063-6394a90a135e | 2025-12-16 | M020 | |
| Non-Tinted Mineral Sunscreen Broad Spectrum SPF 40 | ZINC OXIDE | WECARE FRISCO PLLC | 374fe86e-cbe8-f911-e063-6294a90a9600 | 2025-12-16 | 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 |