PURE Tinted Mineral Sunscreen
- Product NDC
- 85774-203
- 11-digit product format
- 857740203
- Labeler code
- 85774
- Product ID
- 85774-203_46042185-98ac-e8c7-e063-6394a90af605
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- LA JOLLA WELLNESS & AESTHETICS
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-05-09
- 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
- PURE Tinted Mineral Sunscreen
- 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 |
|---|---|
| 386bb911-9dbb-30fb-e063-6394a90a5e4d | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85774-203-15 | PURE Tinted Mineral Sunscreen | 1.5 g in 1 PACKET | CREAM | 1.5 | 2 | |
| 85774-203-50 | PURE Tinted Mineral Sunscreen | 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 |
|---|---|---|---|---|---|---|
| IPKN Moist and Firm Beauty Balm Light Medium | TITANIUM DIOXIDE | Inel Cosmetics Co., Ltd. | 1af6184e-3dc4-4eb3-8d51-aca724473451 | 2024-10-25 | Warnings | M020 |
| IPKN Moist and Firm Beauty Balm Light | TITANIUM DIOXIDE | Inel Cosmetics Co., Ltd. | 77d77838-aa13-4939-a1a0-50189fbb3fe0 | 2024-10-25 | Warnings | M020 |
| Dove Men plus Care Hydrate Face | AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE | CONOPCO Inc. d/b/a Unilever | afe75aff-c056-eaf7-e053-2a95a90af71b | 2024-10-24 | Warnings | M020 |
| Cancer Council Mineral Fluid SPF50 | ZINC OXIDE | Vitality US Co. | 1638f8a4-a2da-4e1f-e063-6294a90a03d9 | 2024-10-24 | Warnings | M020 |
| Marlowe SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Marlowe Holdings, LLC | f94bd91a-f0ab-680c-e053-6394a90ac855 | 2024-10-23 | Warnings | M020 |
| Vacation Broad Spectrum SPF 30 | HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE | Vacation Inc. | 2526eadf-4b55-ff81-e063-6394a90a3ba7 | 2024-10-23 | Warnings | M020 |
| Tenacious Ergodyne | KREWD CLEAR SPF 50 CONTINUOUS SPRAY | Tenacious Holdings, Inc. | 55d99d0a-dc7f-4915-b7c1-f999c8b36e0d | 2024-10-23 | Warnings | M020 |
| Tenacious Ergodyne | SPF 50 SUNSCREEN LOTION | Tenacious Holdings, Inc. | aaaa1f54-1136-4062-85ba-0926351580bb | 2024-10-23 | Warnings | M020 |
| Bull Frog SPF 50 Quik with Water Armor Tech | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BULLFROG BRANDS, LLC. | f706f90c-eb79-2201-e053-6394a90a2ce4 | 2024-10-23 | Warnings | M020 |
| Bull Frog SPF 50 Quik with Water Armor Tech | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BULLFROG BRANDS, LLC. | f70816a3-cc04-b000-e053-6294a90a0fae | 2024-10-23 | Warnings | M020 |
| Alumier MD Post Procedure Kit | TITANIUM DIOXIDE, ZINC OXIDE | Alumier Labs | 252859de-6676-5e07-e063-6394a90a64a1 | 2024-10-23 | Warnings | M020 |
| Equate Sunscreen Tanning Oil With Coconut Oil SPF 6 | AVOBENZONE, HOMOSALATE | WAL-MART STORES INC. | f44d83d3-ffca-7a93-e053-2a95a90a7715 | 2024-10-23 | Warnings | M020 |
| Tanning Sunscreen UVB Protection Dry Oil Equate | AVOBENZONE, HOMOSALATE, OCTISALATE | WAL-MART STORES INC. | acdf62f2-742e-5df9-e053-2a95a90a96c5 | 2024-10-23 | Warnings | M020 |
| WALMART EQUATE BEAUTY ULTRA LIGHT SUNSCREEN SPF 100 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | WAL-MART STORES INC. | c8d4feca-7bee-2413-e053-2a95a90a739c | 2024-10-23 | Warnings | M020 |
| Equate Sunscreen for All Skin Tones SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Wal-Mart Stores Inc | f410ffcc-ef0e-13c4-e053-2a95a90a568a | 2024-10-23 | Warnings | M020 |
| Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44N | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Rare Beauty, LLC | cffbb6af-5a04-f58a-e053-2995a90a1ae2 | 2024-10-23 | Warnings | M020 |
| Banana Boat | TITANIUM DIOXIDE, ZINC OXIDE | Edgewell Personal Care Brands, LLC | 441a46f0-ecda-4448-e054-00144ff88e88 | 2024-10-23 | Warnings | M020 |
| Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28C | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Rare Beauty, LLC | cffb8219-7076-de64-e053-2a95a90a6036 | 2024-10-23 | Warnings | M020 |
| Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10N | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Rare Beauty, LLC | cfee02eb-92f9-be12-e053-2a95a90a4337 | 2024-10-23 | Warnings | M020 |
| CVS Pharmacy Kids SPF 70 Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS Pharmacy | 4eb824a6-66ac-01f8-e054-00144ff8d46c | 2024-10-22 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85774-203-15 | 85774020315 | 1.5 g in 1 PACKET (85774-203-15) | 1.5 g | 2022-05-09 | Yes | No | Current |
| 85774-203-50 | 85774020350 | 53 g in 1 BOTTLE, PUMP (85774-203-50) | 53 g | 2022-05-09 | No | No | Current |