Tinted Mineral Sunscreen
- Product NDC
- 85597-203
- 11-digit product format
- 855970203
- Labeler code
- 85597
- Product ID
- 85597-203_46171295-53fd-c2c3-e063-6394a90acd21
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- ESTHETIC ACADEMY LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-04-29
- 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
- Tinted Mineral Sunscreen
- 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 |
|---|---|
| 36c0c1ca-80a8-9d37-e063-6294a90a824f | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85597-203-15 | Tinted Mineral Sunscreen | 1.5 g in 1 PACKET | CREAM | 1.5 | 2 | |
| 85597-203-50 | 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 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 |
| 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 |
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85597-203-15 | 85597020315 | 1.5 g in 1 PACKET (85597-203-15) | 1.5 g | 2022-04-29 | Yes | No | Current |
| 85597-203-50 | 85597020350 | 53 g in 1 BOTTLE, PUMP (85597-203-50) | 53 g | 2022-04-29 | No | No | Current |