Tinted Sunscreen
- Product NDC
- 85331-208
- 11-digit product format
- 853310208
- Labeler code
- 85331
- Product ID
- 85331-208_45af1972-d2cc-1b3f-e063-6394a90a88dd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Scottsdale Skin Boutique and Dermatology Pllc
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-07-20
- Substance
- ZINC OXIDE
- Active strength
- 160 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 Sunscreen
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 160 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 34a54441-c741-0c46-e063-6294a90a9be8 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85331-208-15 | Tinted Sunscreen | 15 g in 1 PACKET | CREAM | 15 | 2 | |
| 85331-208-50 | Tinted Sunscreen | 53 g in 1 BOTTLE, PUMP | CREAM | 53 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 85331-208 | TINTED SUNSCREEN (ZINC OXIDE) CREAM [SCOTTSDALE SKIN BOUTIQUE AND DERMATOLOGY PLLC] | 1 | Current NDC, 1 package rows | 20250510_34a54441-c741-0c46-e063-6294a90a9be8.zip |
| 85331-208 | TINTED SUNSCREEN (ZINC OXIDE) CREAM [SCOTTSDALE SKIN BOUTIQUE AND DERMATOLOGY PLLC] | 1 | Current NDC, 1 package rows | 20250510_34a66140-0d36-005a-e063-6394a90a2a0b.zip |
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 |
|---|---|---|---|---|---|---|
| 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 |
| MISSHA M Perfect Cover BB No 21 | ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE | Able C&C Co., Ltd. | 9585d3d2-806c-36e3-e053-2a95a90a28fa | 2024-12-04 | Warnings | M020 |
| MISSHA M Perfect Cover BB SPF42 No21 | OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE | Able C&C Co., Ltd. | 3d196cf3-eddd-21d7-e054-00144ff88e88 | 2024-12-04 | Warnings | M020 |
| MISSHA M Perfect Cover BB No 23 | ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE | Able C&C Co., Ltd. | 6a81522e-f4d9-4013-8563-f50f01ff6326 | 2024-12-04 | Warnings | M020 |
| Milani Prime Protect SPF 30 Face Primer | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE | The Milani Group, Inc. | d557d554-5161-482c-bd78-7721c7dc9a6e | 2024-12-04 | Warnings | M020 |
| Pipette Diaper Rash | ZINC OXIDE | Amyris, Inc | ef5ea6f5-0126-47de-9bee-9070c5f6112b | 2024-12-04 | Warnings | M020 |
| Elta MD Skincare UV Stick Broad Spectrum SPF50 | ZINC OXIDE | CP Skin Health Group, Inc | 81a889b8-0719-40c9-b8d4-d9220747ce49 | 2024-12-04 | Warnings | M020 |
| Bright-eyed 100% mineral Eye Cream Broad Spectrum Sunscreen SPF 40 | ZINC OXIDE | Supergoop, LLC | 971ac413-5e69-7553-e053-2995a90a4168 | 2024-12-04 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85331-208-15 | 85331020815 | 15 g in 1 PACKET (85331-208-15) | 15 g | 2022-07-28 | Yes | No | Current |
| 85331-208-50 | 85331020850 | 53 g in 1 BOTTLE, PUMP (85331-208-50) | 53 g | 2022-07-20 | No | No | Current |