Prime And Protect Dewy
- Product NDC
- 85363-204
- 11-digit product format
- 853630204
- Labeler code
- 85363
- Product ID
- 85363-204_4603d0f3-a854-95bc-e063-6394a90a9a7f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Kalon Skin Studio, LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-07-25
- Substance
- ZINC OXIDE
- Active strength
- 200 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 Dewy
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 200 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3593cefe-a08f-eb88-e063-6394a90aaff6 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85363-204-60 | Prime And Protect Dewy | 60 g in 1 BOTTLE, PUMP | CREAM | 60 | 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 |
|---|---|---|---|---|---|---|
| Poolside Golden Hour SPF 15 Sunscreen Lip | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | I World LLC | 7d0f8319-f0fa-4ea7-bb66-427c5a78145a | 2026-02-10 | Warnings | M020 |
| Tanri Broad Spectrum SPF 30 | SUNSCREEN | I. Shay Cosmetics | 26d5b9d1-d669-3430-e063-6394a90ad7f2 | 2026-02-10 | Warnings | M020 |
| DAILY SUNSCREEN BROAD SPECTRUM SPF 30 | ZINC OXIDE | S+ | 9d6ffe56-debc-4ad2-837b-fd7bb091a56f | 2026-02-09 | Warnings | M020 |
| Alumier MD Clear Shield Broad Spectrum SPF 42 Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Alumier Labs | a9c970c8-b6e3-b0a1-e053-2a95a90a89c7 | 2026-02-09 | Warnings | M020 |
| Solavida Broad Spectrum Mineral Sunscreen SPF 30 - Face | ZINC OXIDE | Solavida, LLC | 4a694cdf-496b-3bc0-e063-6294a90af0d1 | 2026-02-09 | Warnings | M020 |
| numbuzin 9 NAD BIO Super Defense Glow Sunscreen Broad Spectrum SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BENOW BEAUTY INC | 32bfb17c-5535-c016-e063-6394a90a1814 | 2026-02-09 | Warnings | M020 |
| TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Trader Joe's Company | 4a6b69ed-2739-d22a-e063-6294a90a1e52 | 2026-02-09 | Warnings | M020 |
| SUNPLUS LIP LIFE | SUNSCREEN | I. Shay Cosmetics | 26d28286-e812-0fb3-e063-6394a90a338d | 2026-02-09 | Warnings | M020 |
| NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Goddess Glow | ZINC OXIDE SUNSCREEN | Bentley Laboratories, LLC | bb86322d-ff30-4a54-97b5-1be275067146 | 2026-02-06 | Warnings | M020 |
| Hampton Sun SPF 50 Mineral | ZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00% | S&C Hampton Sun LLC | d6c33436-042e-44e8-8b55-98be6e246879 | 2026-02-06 | Warnings | M020 |
| SHISEIDO WASO COLOR-SMART DAY MOISTURIZER | OCTINOXATE, TITANIUM DIOXIDE | Shiseido Americas Corporation | f291f077-1c72-48fc-bb19-c20bdeaaa596 | 2026-02-06 | Warnings | M020 |
| SHISEIDO WASO SHIKULIME COLOR CONTROL | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, | Shiseido Americas Corporation | f225a736-2ff7-4084-88a4-a8df5b043cce | 2026-02-06 | Warnings | M020 |
| Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | American Sales Company | 79dff6ec-d958-4bba-999b-da4aa67519f5 | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate, Octocrylene | SUNSCREEN | Retail Business Services, LLC | 1dc325bb-d520-4897-b8f8-3f0ecba2274c | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Sheer Touch Sunscreen SPF 70 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | d8a55217-ae50-4c7f-a440-f4de079d08ae | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Sheer Touch Sunscreen SPF 100 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | f2a4b432-118e-42a4-baeb-90614dccbd06 | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | 232ab407-1903-45d8-a2b2-6992ffd30d00 | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | 0ccef180-0eb1-cf2b-e063-6394a90adf0c | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Sunscreen for Kids SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | 6a455f1a-4285-44c3-820a-85a50d1bbc5b | 2026-02-06 | Warnings | M020 |
| Sport Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | 15bf22f5-a8f5-44bb-b787-2b762b330d61 | 2026-02-06 | Warnings, Adverse reactions | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85363-204-60 | 85363020460 | 60 g in 1 BOTTLE, PUMP (85363-204-60) | 60 g | 2023-07-25 | No | No | Current |