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
- 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
- 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 |
|---|---|---|---|---|---|---|
| TOCOBO Cotton Airy Sun Stick | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | PICTON CO., Ltd. | 55364026-c55a-b370-e063-6294a90ae0d1 | 2026-06-27 | Warnings | M020 |
| Sun Does Matter Daily Face Sunscreen | HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE | Sundoesmatter Company Inc. | 553687d8-d4e1-8361-e063-6294a90a24fe | 2026-06-27 | Warnings | M020 |
| ORLASKIN HYDRATING SUNSCREEN SPF 50 | OCTOCRYLENE ETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE AVOBENZONE | Guangzhou Yapheon Health Industry Co., Ltd. | 552b4c87-4621-d5a7-e063-6294a90a042e | 2026-06-26 | Warnings | M020 |
| Bath and Body Works SPF Waikiki Beach Coconut | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Bath & Body Works, Inc. | 1c30de8a-4d29-bbac-e063-6294a90a84d9 | 2026-06-26 | Warnings | M020 |
| Ivory Perfecting Makeup Broad Spectrum SPF 25 | OCTINOXATE, TITANIUM DIOXIDE | Merle Norman Cosmetics, Inc | 552f25ba-61d5-6a94-e063-6394a90a46e9 | 2026-06-26 | Warnings | M020 |
| Simply Beige Perfecting Makeup Broad Spectrum SPF 25 | OCTINOXATE, TITANIUM DIOXIDE | Merle Norman Cosmetics, Inc | 552f4799-9122-8db5-e063-6394a90a5132 | 2026-06-26 | Warnings | M020 |
| Vanilla Perfecting Makeup Broad Spectrum SPF 25 | OCTINOXATE, TITANIUM DIOXIDE | Merle Norman Cosmetics, Inc | 552f6d2c-9b8c-aa52-e063-6294a90a787e | 2026-06-26 | Warnings | M020 |
| Bath and Body Works SPF Pink Pineapple Sunrise | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Bath & Body Works, Inc. | 1c30a422-b22a-ca79-e063-6294a90a19a9 | 2026-06-26 | Warnings | M020 |
| Bath and Body Works SPF Pink Pineapple Sunrise | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Bath & Body Works, Inc. | 1c37a994-79dd-9720-e063-6294a90a7f34 | 2026-06-26 | Warnings | M020 |
| Bath and Body Works SPF Waikiki Beach Coconut | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Bath & Body Works, Inc. | 1c37b8d7-de72-f534-e063-6294a90aeab7 | 2026-06-26 | Warnings | M020 |
| UV Daily Hydration Tinted | OCTISALAT AND ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 02e71602-13e1-43b3-9cba-a75e46cccacc | 2026-06-25 | Warnings | M020 |
| Coral Isle SPF 50 Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Rocky Mountain | 5515f562-62d9-c6ee-e063-6294a90a9ea6 | 2026-06-25 | Warnings | M020 |
| SPF30 Sunscreen | AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE | Zhejiang Ayan Biotech Co.,Ltd. | 6759b9f7-296a-4c06-9198-b4e824e0bdc9 | 2026-06-25 | Warnings | M020 |
| Delicate Beige Perfecting Makeup Broad Spectrum SPF 25 | OCTINOXATE, TITANIUM DIOXIDE | Merle Norman Cosmetics, Inc | 551928b4-74bb-3f6c-e063-6294a90a6b83 | 2026-06-25 | Warnings | M020 |
| Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25 | OCTINOXATE, TITANIUM DIOXIDE | Merle Norman Cosmetics, Inc | 5519290c-b040-6a37-e063-6394a90a8a1d | 2026-06-25 | Warnings | M020 |
| Soft Bisque Perfecting Makeup Broad Spectrum SPF 25 | OCTINOXATE, TITANIUM DIOXIDE | Merle Norman Cosmetics, Inc | 551ab7d1-dd2f-c6d8-e063-6394a90aff65 | 2026-06-25 | Warnings | M020 |
| Alabaster Perfecting Makeup Broad Spectrum SPF 25 | OCTINOXATE, TITANIUM DIOXIDE | Merle Norman Cosmetics, Inc | 551b8c21-3afc-c804-e063-6294a90a5156 | 2026-06-25 | Warnings | M020 |
| Scalp and Face Sunscreen Broad Spectrum SPF 30 | ZINC OXIDE | Only Balds LLC | 551bf10e-598c-1400-e063-6294a90a4af1 | 2026-06-25 | Warnings | M020 |
| Bare Perfecting Makeup Broad Spectrum SPF 25 | OCTINOXATE, TITANIUM DIOXIDE | Merle Norman Cosmetics, Inc | 552f20b2-9a2e-70f3-e063-6394a90a9337 | 2026-06-25 | Warnings | M020 |
| MORANDIPARK PANTHENOL ULTRA LIGHT SUNSCREEN | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | BRAND GENOME CO., Ltd. | 51c07375-e81d-8572-e063-6394a90ab5b0 | 2026-06-24 | 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 |