Prime and Protect
- Product NDC
- 85557-203
- 11-digit product format
- 855570203
- Labeler code
- 85557
- Product ID
- 85557-203_46278184-553b-d003-e063-6394a90a8ce2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Shannon Cornelsen-Lewandowski
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-09-03
- Substance
- TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 80; 38 mg/g; mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- Prime and Protect
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TITANIUM DIOXIDE | 80 mg/g |
| ZINC OXIDE | 38 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 |
|---|---|
| 36480f7f-37e8-decd-e063-6394a90ada60 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85557-203-15 | Prime and Protect | 1.5 g in 1 PACKET | CREAM | 1.5 | 2 | |
| 85557-203-50 | Prime and Protect | 53 g in 1 BOTTLE, PUMP | CREAM | 53 | 2 |
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 |
|---|---|---|---|---|---|---|
| EVERYRAY SUNCARE SUNSHINE SERUM | EVERYRAY SUNCARE SUNSHINE SERUM | Guangzhou Fantesy Biotechnology Co.,Ltd | 062be336-2af4-10e2-e063-6294a90a480a | 2026-01-05 | Warnings | M020 |
| sunscreen powder | SUNSCREEN POWDER | Guangzhou Fantesy Biotechnology Co.,Ltd | fae8ecaf-7a9c-902b-e053-6394a90a5f31 | 2026-01-05 | Warnings | M020 |
| ORLASKIN HYDRATING SUNSCREEN | ORLASKIN HYDRATING SUNSCREEN | Guangzhou Fantesy Biotechnology Co.,Ltd | 0808b0cd-2cfb-8554-e063-6294a90ad6c4 | 2026-01-05 | Warnings | M020 |
| DALLAS JAMES SKINCARE CO. SPF 50 Sunscreen | DALLAS JAMES SKINCARE CO. SPF 50 SUNSCREEN | Guangzhou Fantesy Biotechnology Co.,Ltd | 225faeec-4f96-e082-e063-6394a90a9a31 | 2026-01-05 | Warnings | M020 |
| LING NEW YORK Save Face Broad Spectrum SPF 30 | LING NEW YORK SAVE FACE BROAD SPECTRUM SPF 30 | Guangzhou Fantesy Biotechnology Co.,Ltd | 1dfa80bd-495a-18fb-e063-6394a90a4d0d | 2026-01-05 | Warnings | M020 |
| Sky and Sol Sunscreen SPF30 | SKY AND SOL SUNSCREEN SPF30 | Guangzhou Fantesy Biotechnology Co.,Ltd | 1d917329-dea2-e792-e063-6294a90a0a0d | 2026-01-05 | Warnings | M020 |
| Sky and Sol Sunscreen SPF50 | SKY AND SOL SUNSCREEN SPF50 | Guangzhou Fantesy Biotechnology Co.,Ltd | 1c699b06-c156-b0da-e063-6294a90a947d | 2026-01-05 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 228fab45-e0d2-f219-e063-6294a90a1ef6 | 2026-01-05 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 228055ec-ff59-4412-e063-6394a90abe14 | 2026-01-05 | Warnings | M020 |
| SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORY | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 236bdb53-d7a5-43a2-8a0c-bce4a5522e26 | 2026-01-05 | Warnings | M020 |
| SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY | AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE | SHISEIDO AMERICAS CORPORATION | 4bd99626-690b-49e8-8c42-a2e2dbca09bf | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE LONG-LASTING HYDRATING VEIL | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | f04ece6c-66b6-48e9-8f6b-e898a538ba00 | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE RADIANT FOUNDATION N I10 | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 05ffb157-5e28-4e94-866d-9e3371480d84 | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE CONCEALER N 1 | TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | eedf8065-8897-4773-9cbb-bab57d2dd04f | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE BRIGHTENING ENHANCER VEIL | OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | bb00d6d7-cc51-4fee-a0df-68bbd5bc50d6 | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE THE FOUNDATION N I10 VERY LIGHT IVORY | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | beefe840-6f32-483b-8a37-2696adb8eea1 | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE PROTECTIVE LIP TREATMENT SPF 25 | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | addd9885-362c-4ce0-9a6e-759e71d8756c | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE PROTECTIVE FORTIFYING n | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE | SHISEIDO AMERICAS CORPORATION | 65ca1240-6ee8-40c0-b62f-3597e0872c6e | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE CORRECTING VEIL n M | ENSULIZOLE, OCTINOXATE, AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | 15a258a0-61c3-4419-bcdb-a8197d5ae46f | 2026-01-05 | Warnings | M020 |
| Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | LG H&H Co.,Ltd. | 098c0a9b-2b96-6be3-e063-6294a90a959a | 2026-01-05 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85557-203-15 | 85557020315 | 1.5 g in 1 PACKET (85557-203-15) | 1.5 g | 2021-09-03 | Yes | No | Current |
| 85557-203-50 | 85557020350 | 53 g in 1 BOTTLE, PUMP (85557-203-50) | 53 g | 2021-09-03 | No | No | Current |