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 |
|---|---|---|---|---|---|---|
| MISSHA ALL AROUND VITA C SUNSCREEN | ZINC OXIDE, HOMOSALATE, ETHYLHEXYL SALICYLATE, TITANIUM DIOXIDE | Able C&C Co., Ltd. | 1a7ec673-328a-8924-e063-6294a90a2f3d | 2024-12-05 | Warnings | M020 |
| (Re)Setting Refreshing Mist SPF 40 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Supergoop, LLC | d4d8f28d-cb00-298d-e053-2995a90a10eb | 2024-12-05 | Warnings | M020 |
| KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc | 2ba71f81-54d0-4955-9bae-2b6e35c9c35f | 2024-12-05 | Warnings | M020 |
| Cay Skin Isle Glow Body SPF 45 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Cay Skin, Inc. | db5f6bad-65ae-2b05-e053-2a95a90a8569 | 2024-12-05 | Warnings | M020 |
| Cay Skin Isle Glow Face SPF 45 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Cay Skin, Inc. | d91bba06-fd9b-3eb5-e053-2995a90a6124 | 2024-12-05 | Warnings | M020 |
| Whoa Glow broad spectrum spf 30 sunscreen Sheer Bronze shimmer | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc | 65de9491-8804-4e3b-90a7-9b253e34b7d3 | 2024-12-05 | Warnings | M020 |
| Whoa Glow broad spectrum spf 30 sunscreen Sheer Champagne shimmer sunlight | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc | 499e5352-fcc4-4434-96f2-4375816991c9 | 2024-12-05 | Warnings | M020 |
| Cay Skin Isle Sheen Sunstick SPF 35 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Cay Skin, Inc. | 288c3aeb-01b2-ce39-e063-6394a90ad04a | 2024-12-05 | Warnings | M020 |
| Cay Skin MoBay Mineral Sunscreen Drops SPF 30 | ZINC OXIDE | Cay Skin, Inc. | 288d5456-98f3-a998-e063-6294a90a8366 | 2024-12-05 | Warnings | M020 |
| Solar Moisturizer SPF 30 | OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE | Allure Labs, LLC | ef4d54bf-25f5-4261-9d3d-c42b0d892275 | 2024-12-05 | Warnings | M020 |
| Clear Clear Zinc Solar Protection SPF 30 | ZINC OXIDE | Allure Labs, LLC | 79a3c8e2-c4f2-4c00-8e94-494654ae91a2 | 2024-12-05 | Warnings | M020 |
| LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OXYBENZONE | Aramis Inc. | 8b206b6d-92e4-48bc-a40c-93ffdd635535 | 2024-12-05 | Warnings | M020 |
| Kids Broad Spectrum SPF 35 | ZINC OXIDE | Allure Labs, LLC | b72caf9b-46df-f30c-e053-2995a90a9b6d | 2024-12-05 | Warnings | M020 |
| CBD Blue Light Defense SPF 30 | ZINC OXIDE | Allure Labs | b63b99af-2ddb-3535-e053-2a95a90a65d5 | 2024-12-05 | Warnings | M020 |
| AHAVA CC SPF 30 | AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | AHAVA - Dead Sea Laboratories Ltd | 2fa6249a-9614-455c-8e07-9b829f3b0c22 | 2024-12-04 | Warnings | M020 |
| EGF FGF DNA UV SHIELD | ETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATE | Dermaesthetics Inc. | 13e2630d-9915-4287-91fd-deb672150131 | 2024-12-04 | Warnings | M020 |
| SUNSCREEN 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | e98c3b64-edcb-16c7-e053-2a95a90a8a0e | 2024-12-04 | Warnings | M020 |
| Sun ,Bug Handsfree 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | f8f29aec-935f-e828-e053-6394a90a570a | 2024-12-04 | Warnings | M020 |
| sunscreen 01 | AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | e9e3ecc1-3f13-1d0e-e053-2a95a90ac7f8 | 2024-12-04 | Warnings | M020 |
| MISSHA M Perfect Cover BB No 13 | ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE | Able C&C Co., Ltd. | 95846b5e-5b72-26bc-e053-2a95a90ae0f7 | 2024-12-04 | 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 |