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
- 2027-12-31
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 |
|---|---|---|---|---|---|---|
| Dove Men plus Care Hydrate Face | AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE | CONOPCO Inc. d/b/a Unilever | 5c28d679-3f92-49e3-8bef-de1c3870f009 | 2024-11-07 | Warnings | M020 |
| Mele Men plus Care Hydrate Face | NO SHADE SUNSCREEN OIL | CONOPCO Inc. d/b/a Unilever | bb2921bc-8892-1db2-e053-2995a90ae28c | 2024-11-07 | Warnings | M020 |
| Ponds | REJUVENESS ANTI-WRINKLE DAILY MOISTURIZER WITH SUNSCREEN SPF 30 | CONOPCO Inc. d/b/a Unilever | 736ee790-99f7-686c-e053-2a91aa0ad16e | 2024-11-07 | Warnings | M020 |
| Mele Men plus Care Hydrate Face | DEW THE MOST SHEER MOISTURIZER SUNSCREEN | CONOPCO Inc. d/b/a Unilever | bb27185b-5732-a648-e053-2a95a90aa930 | 2024-11-07 | Warnings | M020 |
| Ponds | CLARANT B3 EVEN SKIN TONE DAILY MOISTURIZER WITH SUNSCREEN SPF 30 | CONOPCO Inc. d/b/a Unilever | 736ee790-9a15-686c-e053-2a91aa0ad16e | 2024-11-07 | Warnings | M020 |
| Byoma Ultralight Face Fluid SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BYOMA LIMITED | 2657bca4-bdc7-d959-e063-6394a90a2aa1 | 2024-11-07 | Warnings | M020 |
| Byoma Ultralight Face Fluid SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BYOMA LIMITED | 2658df86-8cbb-83dd-e063-6394a90ac4e8 | 2024-11-07 | Warnings | M020 |
| SPF30 EVERYDAY/YEAR-ROUND SUNSCREEN | TITANIUM DIOXIDE | ORGANIC & SUSTAINABLE BEAUTY | 547388c6-378b-488b-89d1-c77ebc5d2ed8 | 2024-11-07 | Warnings | M020 |
| SPF30 SUMMER BLEND SUNSCREEN | TITANIUM DIOXIDE | ORGANIC & SUSTAINABLE BEAUTY | 9641b71a-81f2-4157-801b-162188392a91 | 2024-11-07 | Warnings | M020 |
| SPF30 SUPER SENSITIVE SUNSCREEN | TITANIUM DIOXIDE | ORGANIC & SUSTAINABLE BEAUTY | d79cf2d9-4923-452a-bb44-67e059ee37ee | 2024-11-07 | Warnings | M020 |
| SPF30 EVERYDAY/YEAR-ROUND SUNSCREEN | TITANIUM DIOXIDE | ORGANIC & SUSTAINABLE BEAUTY | d4f30d95-4a3f-49ad-817e-faa86fca5018 | 2024-11-07 | Warnings | M020 |
| Round Lab Birch Juice Moisturizing UVLOCK Sun Cushion | ZINC OXIDE | SEORIN COMPANY Co., Ltd. | 26407b83-b417-6450-e063-6294a90ad2b1 | 2024-11-06 | Warnings | M020 |
| e.l.f. Holy Hydration Face Cream SPF 30 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc | b7898d65-df86-580a-e053-2a95a90a5b1b | 2024-11-06 | Warnings | M020 |
| Bondi Sands Fragrance Free SPF 50 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BONDI SANDS (USA) INC. | acda604c-27cf-d500-e053-2995a90a5d65 | 2024-11-06 | Warnings | M020 |
| Bondi Sands Fragrance Free SPF 50 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BONDI SANDS (USA) INC. | acb92160-1749-d51b-e053-2995a90a9e87 | 2024-11-06 | Warnings | M020 |
| Bondi Sands Toasted Coconut Lip Balm with SPF 50 Sunscreen | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | BONDI SANDS (USA) INC. | acb8513e-723b-b7d6-e053-2995a90aed52 | 2024-11-06 | Warnings | M020 |
| Bondi Sands Fragrance Free Face SPF 50 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BONDI SANDS (USA) INC. | acda9863-ad9f-e430-e053-2995a90a69a6 | 2024-11-06 | Warnings | M020 |
| Birch Juice Moisturizing UVLOCK Sunstick SPF 50 Broad Spectrum | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | SEORIN COMPANY Co., Ltd. | 26442417-f238-1fc3-e063-6394a90a6f82 | 2024-11-06 | Warnings | M020 |
| Avene Mineral Sunscreen Face and Body | ZINC OXIDE | Pierre Fabre USA Inc. | fb5b1e94-bed3-8486-e053-6294a90a3a84 | 2024-11-06 | Warnings | M020 |
| Avene Cleanance Mattifying SPF 30 | ZINC OXIDE | Pierre Fabre USA Inc. | 2644f545-0625-7858-e063-6394a90a5963 | 2024-11-06 | 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 |