Tinted Mineral Sunscreen
- Product NDC
- 85585-203
- 11-digit product format
- 855850203
- Labeler code
- 85585
- Product ID
- 85585-203_46161253-7b9f-afb1-e063-6394a90a64d5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-05-30
- Substance
- ZINC OXIDE; TITANIUM DIOXIDE
- Active strength
- 38; 80 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
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 38 mg/g |
| TITANIUM DIOXIDE | 80 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
| 15FIX9V2JP | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 36c0400b-8ad9-654b-e063-6294a90ad040 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85585-203-15 | Tinted Mineral Sunscreen | 1.5 g in 1 PACKET | CREAM | 1.5 | 2 | |
| 85585-203-50 | 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 |
|---|---|---|---|---|---|---|
| CVS SPF 60 Face Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS | 26d1b568-ad9c-80d7-e063-6394a90a2cbf | 2025-09-21 | Warnings | M020 |
| Radiant Shield Tinted Mineral Sunscreen SPF 40 | ZINC OXIDE | CosMedical Technologies, LLC | f229b928-49fd-4e02-99c1-b2cd9166894f | 2025-09-19 | Warnings | M020 |
| EquateDaytimeFaceLotion | EQUATE DAYTIME FACE LOTION WITH SUNSCREEN, SPF 30, 3 OZ | Walmart Inc. | 2efc7087-f4ad-2f2e-e063-6394a90a1302 | 2025-09-18 | Warnings | M020 |
| ERBORIAN CC RED CORRECT | ERBORIAN CC RED CORRECT SPF 25- OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM | Kolmask Co., Ld. | 09ca2d4b-e0c2-9961-e063-6394a90aa82e | 2025-09-18 | M020 | |
| ELROEL Pang Pang Sun Cushion Plus | ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE | MONOGLOT HOLDINGS Inc. | 5ffaad65-f0b2-416a-b0a3-b92e880641e4 | 2025-09-18 | Warnings | M020 |
| e.l.f. Camo CC Cream SPF 30 Fair 125 C | HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE | e.l.f. Cosmetics, Inc. | 407f9c0d-31c6-f5bb-e063-6394a90a4db4 | 2025-09-18 | Warnings | M020 |
| Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Kenvue Brands LLC | 1630feee-7e0d-c6f4-e063-6294a90a7b1c | 2025-09-17 | Warnings | M020 |
| Guise Tinted Drops | ZINC OXIDE | Donis Men LLC | 3f039049-5004-2888-e063-6294a90a5150 | 2025-09-17 | Warnings | M020 |
| ONE SIZE ON TIL DAWN | ONE SIZE ON TIL DAWN | Pogi Beauty LLC | 3f05d90b-9274-4d21-e063-6294a90a8485 | 2025-09-17 | Warnings | M020 |
| PUR 4-in-1 Skin Tint DP3 | ZINC OXIDE | PUR Minerals | 3f073413-b314-e5da-e063-6394a90a9ab4 | 2025-09-17 | Warnings | M020 |
| e.l.f. Hydrating Camo CC Cream SPF30 Fair 100 W | HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE | e.l.f. Cosmetics, Inc. | 3fa7ef54-2c4d-9883-e063-6294a90a8d88 | 2025-09-17 | Warnings | M020 |
| CVS SPF 50 Face Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | CVS | 26a69a47-947a-a478-e063-6394a90aa468 | 2025-09-16 | Warnings | M020 |
| SkinSuit TM 3 in 1 Moisturizer SPF 50 | ZINC OXIDE | Skin Authority LLC | 5eb27be9-9e80-4f4a-b193-b918d831555d | 2025-09-15 | Warnings | M020 |
| Sun and Honey Tallow Sunscreen SPF 30 | ZINC OXIDE | Amara Ventures | 3eda8a70-7c9e-e920-e063-6394a90a85a2 | 2025-09-15 | Warnings | M020 |
| Klein Tools Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | KLEIN TOOLS, INC. | 3edcc26a-d960-3fa8-e063-6394a90ab703 | 2025-09-15 | Warnings | M020 |
| Klein Tools Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | KLEIN TOOLS, INC. | 3ede5e54-4c9f-02f7-e063-6294a90a9df6 | 2025-09-15 | Warnings | M020 |
| I.C. Industrial Sunscreen | ZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATE | R & R Lotion, Inc | b89d687a-7b36-4643-9817-765d4710ca60 | 2025-09-15 | Warnings | M020 |
| Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Kenvue Brands LLC | 97795f0e-d867-4e17-b7c9-ede08e7df70c | 2025-09-12 | Warnings | M020 |
| Oh My Bod Light Sunscreen Broad Spectrum SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Baxter Laboratories Pty. Ltd. | 3e9db4f5-d9d9-ddf3-e063-6394a90a99fc | 2025-09-12 | Warnings | M020 |
| Dolce and Gabbana Blueberry Nutri Tint SPF 20 36N Deep | ZINC OXIDE | DOLCE & GABBANA BEAUTY S.R.L. | 2d05659c-57d2-4faf-ab67-1b8d68945aed | 2025-09-12 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85585-203-15 | 85585020315 | 1.5 g in 1 PACKET (85585-203-15) | 1.5 g | 2021-03-23 | Yes | No | Current |
| 85585-203-50 | 85585020350 | 53 g in 1 BOTTLE, PUMP (85585-203-50) | 53 g | 2025-05-30 | No | No | Current |