Prime Protection Sunscreen, tinted
- Product NDC
- 85641-203
- 11-digit product format
- 856410203
- Labeler code
- 85641
- Product ID
- 85641-203_45c73b28-999c-0a5c-e063-6394a90ab90a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- KRISTI REDD ESTHETICS
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-04-21
- Substance
- TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 80; 38 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
- Prime Protection Sunscreen, tinted
- Listing expiration
- 2027-12-31
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 |
|---|---|
| 3660af9e-d60f-c33e-e063-6394a90a3a05 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85641-203-15 | Prime Protection Sunscreen, tinted | 1.5 g in 1 PACKET | CREAM | 1.5 | 2 | |
| 85641-203-50 | Prime Protection Sunscreen, tinted | 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 |
|---|---|---|---|---|---|---|
| glo SKIN BEAUTY Oil-Free Tinted Primer SPF 30 | GLO SKIN BEAUTY OIL-FREE TINTED PRIMER SPF 30 | Hayden Caleel LLC | 00bf7331-c9dc-4a8a-9ff3-901e0d07eac6 | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen Sunscreen SPF 30 Broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Black Girl Sunscreen, LLC | 2bc42f6f-4eaf-fa28-e063-6294a90a93fb | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen SPF 50 Broad Spectrum | HOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDE | Black Girl Sunscreen, LLC | 2bc419b3-4de2-7ed9-e063-6394a90a255f | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen SPF 45 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Black Girl Sunscreen, LLC | 2bc47bd0-d81b-f1b9-e063-6394a90ad375 | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen SPF 50 | OCTOCRYLENE, OCTISALATE, HOMOSALATE, AVOBENZONE | Black Girl Sunscreen, LLC | 2bc46854-fe67-782b-e063-6294a90a79af | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen SPF 50 broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE | Black Girl Sunscreen, LLC | 2bc471f0-c93e-0c51-e063-6394a90a77f0 | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen SPF 45 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Black Girl Sunscreen, LLC | 2bc4b1b1-5f19-7ba3-e063-6394a90a5de7 | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Black Girl Sunscreen, LLC | 2bc4c639-787a-d2d3-e063-6394a90a5ded | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Black Girl Sunscreen, LLC | 2bc4d937-77d0-273c-e063-6394a90a25e7 | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Black Girl Sunscreen, LLC | 2bc4cfd9-e44c-9b93-e063-6394a90a96a6 | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Black Girl Sunscreen, LLC | 2bc4e22d-6265-9c0b-e063-6394a90a1541 | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Black Girl Sunscreen, LLC | 2bc4eb32-8c0b-32fc-e063-6294a90a1625 | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Black Girl Sunscreen, LLC | 2bc50182-30f2-b77e-e063-6394a90a6355 | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Black Girl Sunscreen, LLC | 2bc50182-30f5-b77e-e063-6394a90a6355 | 2025-01-15 | Warnings | M020 |
| MEDIFORDEAR CICA CALMING SUNSCREEN | HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, AVOBENZONE | Youngwon Costech Co.,ltd. | 2bc94923-b221-5159-e063-6394a90ab8ff | 2025-01-15 | Warnings | M020 |
| Meaningful Beauty Cindy Crawford Anti-Aging Day Creme with Environmental Protection Broad Spectrum SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OXYBENZONE | Meaningful Beauty, LLC | 6423e1c7-85cd-46f8-8fc9-a7284e3577d1 | 2025-01-15 | Warnings | M020 |
| Stay AgelessTinted Sunscreen Broad Spectrum SPF 30 | TITANIUM DIOXIDE AND ZINC OXIDE | Spectrum Aesthetics Laser Training LLC | 026b9b30-ef08-bf2e-e063-6394a90a54a6 | 2025-01-14 | Warnings | M020 |
| Daily Sunscreen Broad Spectrum SPF 30 UVA UVB | MINERAL SUNSCREEN SPF 30 | IHerb, LLC | 2d8101ef-96a3-1463-e063-6294a90add4d | 2025-01-14 | Warnings | M020 |
| ATTITUDE Sunly Tinted Mineral Sunscreen Face Stick Unscented SPF 30 | ZINC OXIDE | 9055-7588 Quebec Inc. DBA Attitude | 0d85b0a1-3705-2829-e063-6394a90a0ed7 | 2025-01-13 | Warnings | M020 |
| Attitude mineral sunscreen orange blossom SPF 30 | ZINC OXIDE | 9055-7588 Quebec Inc. DBA Attitude | 0b85ea68-6113-4e92-a10a-39d13099d12d | 2025-01-13 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85641-203-15 | 85641020315 | 1.5 g in 1 PACKET (85641-203-15) | 1.5 g | 2021-04-21 | Yes | No | Current |
| 85641-203-50 | 85641020350 | 53 g in 1 BOTTLE, PUMP (85641-203-50) | 53 g | 2021-04-21 | No | No | Current |