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 |
|---|---|---|---|---|---|---|
| CLARINS Multi-Active Jour Niacinamide and Sea Holly Extract Sunscreen SPF 15 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Laboratoires Clarins | a43d0d4f-94de-4c4b-a17a-63a819d5d293 | 2025-04-07 | Warnings | M020 |
| Gangnam Glow Sunscreen 50 | AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | LG HOUSEHOLD & HEALTH CARE LTD. | 30cc2e35-f752-8285-e063-6294a90afbf5 | 2025-04-07 | Warnings | M020 |
| Carmex Daily Care Moisturizing Lip Balm SPF 15 | OCTINOXATE, OXYBENZONE | Carma Laboratories, Inc. | 26f8dc88-2096-4fa1-81ae-ea92fe1f353d | 2025-04-07 | Warnings | M020 |
| Vacation Instant Browning | AVOBENZONE OCTISALATE OCTOCRYLENE | Vacation Inc. | 13028f61-3f62-22cc-e063-6394a90a6bf1 | 2025-04-04 | Warnings | M020 |
| LBri Pure n Natural SPF 30 | ZINC OXIDE | L'BRI HEALTH & BEAUTY | 8350791d-5cf2-4358-9f85-9384d35be9f4 | 2025-04-03 | Warnings | M020 |
| SHEER MINERAL SUNSCREEN | ZINC OXIDE | Plant Devas Inc. dba evanhealy | f620ef44-f30c-4cc9-bc82-28dc4a47a8da | 2025-04-02 | Warnings | M020 |
| CLEAR GLOW BROAD SPECTRUM SUNCREEN SPF 50 | AVOBENZONE, HOMOSALATE OCTISALATE, OCTOCRYLENE | NAKED SUNDAYS PTY LTD | 0116cffa-3415-746b-e063-6394a90ab3b3 | 2025-04-01 | Warnings | M020 |
| HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50 | AVOBENZONE, HOMOSALATE OCTISALATE, | NAKED SUNDAYS PTY LTD | 04293280-e74a-f293-e063-6394a90a06f6 | 2025-04-01 | Warnings | M020 |
| Glow Go Lip Oil | AVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G, | NAKED SUNDAY PTY LTD | e5aab267-b33b-a40d-e053-2a95a90a9d79 | 2025-04-01 | Warnings | M020 |
| Glow Go Lip Oil | AVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G, | NAKED SUNDAY PTY LTD | e5beb9cd-aa3b-2b37-e053-2995a90a8409 | 2025-04-01 | Warnings | M020 |
| Glow Go Lip Oil | AVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G, | NAKED SUNDAY PTY LTD | e5bdc0c8-af2c-1096-e053-2995a90a8917 | 2025-04-01 | Warnings | M020 |
| Mesoestetic Mesoprotech Melan 130 Pigment Control | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | MESOESTETIC PHARMA GROUP SL | 3b50e874-9665-4df4-8b3a-fc932c29f3f6 | 2025-04-01 | Warnings | M020 |
| AVON BEYOND GLOW SUN MOISTURIZER | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | LG HOUSEHOLD & HEALTH CARE LTD. | 30c83f4f-9de0-6fbf-e063-6394a90af1ae | 2025-04-01 | Warnings | M020 |
| EltaMD UV Daily | OCTINOXATE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 6dde7055-5f77-4a7f-a182-c03e1f30bfaa | 2025-03-31 | Warnings | M020 |
| natural lip balm SPF15( chocolate sundae) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 319e8e26-b29d-4627-e063-6294a90acfba | 2025-03-31 | Warnings | M020 |
| Face Shield Cream SPF 30 | OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE | Vege Labs | 31aad575-a5d1-42b0-e063-6294a90a6c81 | 2025-03-31 | Warnings | M020 |
| SOLMED SUNSCREEN FACE SHIELD | AVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE | FEELFREE LLC | 31b077cc-32b9-78e6-e063-6394a90a155a | 2025-03-31 | Warnings | M020 |
| TATCHA THE SILK SUNSCREEN | ZINC OXIDE | TATCHA INC. | 7799042a-d2de-480e-a8a3-827b3dc27907 | 2025-03-31 | Warnings | M020 |
| Cotz Sensitive SPF 40 Sunscreen | ZINC OXIDE | Fallien Cosmeceuticals, LTD. | 885a674b-3457-4dfe-a801-529094b00499 | 2025-03-31 | Warnings | M020 |
| EltaMD UV Daily Tinted | OCTINOXATE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | ad8aafdf-f3bc-497f-9792-20c2911c12d0 | 2025-03-31 | 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 |