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 |
|---|---|---|---|---|---|---|
| BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 40 | OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE | Bobbi Brown Professional Cosmetics Inc. | dc6b28ca-b922-460a-8028-fb3f5afdbe9d | 2024-12-16 | Warnings | M020 |
| BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 30 | OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDE | Bobbi Brown Professional Cosmetics Inc. | 1f9a4b71-45aa-4156-9fe6-ffa81f808a85 | 2024-12-16 | Warnings | M020 |
| AHAVA Protecting Moisturizing SPF50 | AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | AHAVA - Dead Sea Laboratories Ltd | 7502e06d-754b-4cb8-ba4c-91eee0453932 | 2024-12-16 | Warnings | M020 |
| Natural Finish Pressed Foundation SPF 20 Sunscreen | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | c389e183-bfad-4813-af09-fae3aa05e82a | 2024-12-16 | Warnings | M020 |
| Sunforgettable Total Protection Brush-On Shield SPF 50 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | c77357f1-7ada-4325-86f7-5ee801610f42 | 2024-12-16 | Warnings | M020 |
| Sunforgettable Total Protection Sheet Matte Sunscreen SPF 30 | ZINC OXIDE | Colorescience | 5b6f906e-6620-48b0-9c39-0eb1c8dc1c63 | 2024-12-16 | Warnings | M020 |
| Ryshi SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Rite Aid | e313350f-74d9-370b-e053-2995a90aeeaf | 2024-12-15 | Warnings | M020 |
| Annmarie SPF 20 Sunscreen | ZINC OXIDE 15% | Annmarie Gianni Skin Care LLC | cc722ce1-0ded-19d5-e053-2995a90a7d03 | 2024-12-15 | Warnings | M020 |
| Zinka SPF 30 Clear Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8% | Zinka, Inc | c054ac39-d03f-17c1-e053-2a95a90aa5ef | 2024-12-15 | Warnings | M020 |
| QC SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | CDMA | f82080b1-ef90-a027-e053-6294a90a19f2 | 2024-12-15 | Warnings | M020 |
| QC SPF 30 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6% | CDMA | f80ceb05-0bd4-1355-e053-6294a90afb19 | 2024-12-15 | Warnings | M020 |
| Lip Shine SPF35 Sunscreen | ZINC OXIDE | Colorescience | 3a6506c4-1ba9-493a-a4c8-e5f9c60d221b | 2024-12-13 | Warnings | M020 |
| MILK TINT SPF 43 TINTED PRIMER SERUM DEEP | ZINC OXIDE | COSMAX USA, CORPORATION | 292165af-545d-db43-e063-6394a90ad183 | 2024-12-13 | Warnings | M020 |
| Tinted Lip Cream SPF 15 | ZINC OXIDE | COSMAX USA, CORPORATION | 29227121-e579-8eea-e063-6394a90a302f | 2024-12-13 | Warnings | M020 |
| BOBBI BROWN PRIMER PLUS PROTECTION BROAD SPECTRUM SPF50 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,AND OXYBENZONE | Bobbi Brown Professional Cosmetics Inc. | 03372376-ef03-943d-e063-6394a90a52ee | 2024-12-13 | Warnings | M020 |
| WEIGHTLESS SKIN FOUNDATION BROAD SPECTRUM SPF 15 | OCTINOXATE, TITANIUM DIOXIDE | Bobbi Brown Professional Cosmetics Inc. | fbd04b66-738b-2762-e053-6394a90a8b72 | 2024-12-13 | Warnings | M020 |
| Mentholatum Natural Ice Cherry | DIMETHICONE, OCTINOXATE, OCTISALATE | The Mentholatum Company | 33f43f14-8e0b-41b1-8ad0-5723d2a7bf19 | 2024-12-13 | Warnings | M020 |
| Absolutely Natural Broad Spectrum SPF 8 Sunscreen | ZINC OXIDE | Absolutely Natural | a26217cf-22ab-4c39-980a-b73467e16b91 | 2024-12-13 | Warnings | M020 |
| Calming Primer SPF 20 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | d681cdb5-307e-4a2a-8e1d-2b29131d48d0 | 2024-12-13 | Warnings | M020 |
| Absolutely Natural Broad Spectrum SPF 15 Sunscreen | ZINC OXIDE | Absolutely Natural | 8084a3ee-fe31-4cb4-8d3c-e4035d29e561 | 2024-12-13 | 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 |