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 |
|---|---|---|---|---|---|---|
| Banana Boat | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | Edgewell Personal Care Brands LLC | 7961ff9f-75db-4977-e053-2a91aa0ae628 | 2024-10-27 | Warnings | M020 |
| Banana Boat Light as air face SUNSCREEN UVA UVB Broad Spectrum SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Edgewell Personal Care Brands LLC | 8a1c9a3c-394e-9122-e053-2995a90acb23 | 2024-10-27 | Warnings | M020 |
| Banana Boat | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | Edgewell Personal Care Brands LLC | 8b889b75-07ac-4276-e053-2a95a90a69c6 | 2024-10-27 | Warnings | M020 |
| Banana Boat Ultra Sport Sunscreen Broad Spectrum SPF 15 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands, LLC | 9751a700-5d51-357b-e053-2a95a90af66c | 2024-10-27 | Warnings | M020 |
| Banana Boat Sport Ultra Face SPF30 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | dc757b03-7e7d-b362-e053-2a95a90a8446 | 2024-10-27 | Warnings | M020 |
| Banana Boat Kids Mineral Protection SPF50 | TITANIUM DIOXIDE,ZINC OXIDE | Edgewell Personal Care Brands LLC | dc7701b5-0c73-b4df-e053-2a95a90a0f1b | 2024-10-27 | Warnings | M020 |
| Banana Boat Mineral Sensitive SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Edgewell Personal Care Brands LLC | dc7913d5-58f2-3077-e053-2a95a90a1627 | 2024-10-27 | Warnings | M020 |
| BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | e5f9d56d-a80e-221c-e053-2a95a90aae92 | 2024-10-27 | Warnings | M020 |
| Banana Boat Mineral Sensitive Face SPF50 | TITANIUM DIOXIDE, ZINC OXIDE | Edgewell Personal Care Brands LLC | dc783438-b28f-b7f4-e053-2a95a90a3d65 | 2024-10-27 | Warnings | M020 |
| BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | e53509bf-6bb7-2db7-e053-2a95a90aae18 | 2024-10-27 | Warnings | M020 |
| Banana Boat Sport Mineral SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Edgewell Personal Care Brands LLC | dc79790f-e2bc-5414-e053-2a95a90a9e7a | 2024-10-27 | Warnings | M020 |
| Hawaiian Tropic Everyday Active SPF15 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | dc8ca3ed-5411-6278-e053-2995a90a0efc | 2024-10-27 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 16b4342e-6705-ca09-e063-6294a90a947d | 2024-10-27 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | Edgewell Personal Care Brands LLC | 17670182-2b2e-ce40-e063-6294a90a2913 | 2024-10-27 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 16b3c10c-d98b-c424-e063-6394a90a7734 | 2024-10-27 | Warnings | M020 |
| TiZO Mineral Stick - Tinted SPF 45 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | fd6d0080-0bef-4e7e-8ca5-b859639efd0c | 2024-10-25 | Warnings | M020 |
| Alumier MD Post Procedure Kit with Hydrocortisone | TITANIUM DIOXIDE, ZINC OXIDE, HYDROCORTISONE | Alumier Labs | 2551d748-c3d6-cd18-e063-6294a90adab6 | 2024-10-25 | Warnings | M020 |
| TiZO Mineral Stick Non-Tinted SPF 45 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | e7044f18-992a-4f60-9a2b-f11ed06db09b | 2024-10-25 | Warnings | M020 |
| CoTZ Lip Balm | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | 479a7d82-a068-4c2e-b50b-555c40e13e37 | 2024-10-25 | Warnings | M020 |
| TiZO Mineral Sun Defense SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals Ltd. | e17a8c35-2d49-4c99-b154-ea673c14753e | 2024-10-25 | 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 |