Mineral Lip Protection
- Product NDC
- 85563-212
- 11-digit product format
- 855630212
- Labeler code
- 85563
- Product ID
- 85563-212_46041f25-f600-ee00-e063-6394a90aaa56
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- STICK
- Route
- TOPICAL
- Labeler
- CLEAR SKIN SOLUTIONS, LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-07-11
- Substance
- ZINC OXIDE; TITANIUM DIOXIDE
- Active strength
- 55; 40 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
- Mineral Lip Protection
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 55 mg/g |
| TITANIUM DIOXIDE | 40 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 |
|---|---|
| 35bd148c-43c7-aa93-e063-6394a90abc8b | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85563-212-45 | Mineral Lip Protection | 4.5 g in 1 CYLINDER | STICK | 4.5 | 2 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Mineral Lip Balm SPF-15 | ZINC OXIDE | TUBBY TODD | 4d938672-5302-4e47-a582-c3e6467008cb | 2024-12-18 | Warnings | M020 |
| SaltyFace Daily Sun Shield Mineral Sunscreen For Face SPF 30 | ZINC OXIDE | Saltyface Natural Inc | f0cc7ce9-81b3-439f-b5ee-96138de54e78 | 2024-12-18 | Warnings | M020 |
| Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50 Jasmine | TITANIUM DIOXIDE, ZINC OXIDE | EK Clothing LLC dba Belasol | e999d752-6c00-459e-b6c3-d264c330597d | 2024-12-18 | Warnings | M020 |
| Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | EK Clothing LLC dba Belasol | f22626c1-0996-41d8-a2ec-3bf7491df657 | 2024-12-18 | Warnings | M020 |
| Costa Sea Mineral Sunscreen SPF 50 | ZINC OXIDE | COSTA SEA INC | 841e1b3d-dbbc-4bb0-886a-fb2d077ae739 | 2024-12-18 | Warnings | M020 |
| SPF 50 plus Sunscreen All Mineral Active Ingredients | TITANIUM DIOXIDE AND ZINC OXIDE | KAS Direct LLC dba BabyGanics | 247aae3d-1845-4dd8-b774-b9e8214809a2 | 2024-12-18 | Warnings | M020 |
| Softlips Vanilla, Watermelon, Cherry | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 2235d029-157e-4a30-be90-605e6bc143fd | 2024-12-17 | Warnings | M020 |
| Softlips Salted Caramel, Candy Apple, Marshmallow Ghost | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 42cf4623-0eb8-455a-b374-8e17e9336b92 | 2024-12-17 | Warnings | M020 |
| Softlips Peppermint Mocha, Apple Chai Cider, Orange Cranberry | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 0338c078-695d-4d4e-9e90-5a8a98d49524 | 2024-12-17 | Warnings | M020 |
| Softlips Pearl Plus Vanilla | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 107bcaa9-4347-4979-be44-35183a9ee67e | 2024-12-17 | Warnings | M020 |
| Softlips Raspberry | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | d18b4c19-0365-44ec-bea8-4328e537e0d8 | 2024-12-17 | Warnings | M020 |
| Softlips Watermelon | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 03062f13-270d-49cf-8939-2349f12e9cba | 2024-12-17 | Warnings | M020 |
| Softlips Vanilla Watermelon | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | f733747a-ad1a-4222-baf1-69dcd90a3350 | 2024-12-17 | Warnings | M020 |
| Softlips Vanilla Watermelon | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 1fbe85a2-4cd7-45bd-85a2-83bbf75c5f97 | 2024-12-17 | Warnings | M020 |
| Softlips Marshmallow Ghost | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 8d55141d-5d6f-4eec-87dc-d3c808cf7a6a | 2024-12-17 | Warnings | M020 |
| Softlips Pearl | OCTINOXATE, OCTISALATE | The Mentholatum Company | 43e175b4-7a48-431e-bf27-9ce7dee53f5e | 2024-12-17 | Warnings | M020 |
| Softlips Oasis Watermelon Blackberry | DIMETHICONE, OXYBENZONE, OCTINOXATE | The Mentholatum Company | e1213808-4dad-4fd0-871a-04bba094a3cc | 2024-12-17 | Warnings | M020 |
| Softlips Peppermint | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 1a0062f1-fcfc-4d6a-8274-2ebbc5fbdb27 | 2024-12-17 | Warnings | M020 |
| Softlips Oasis Pineapple Coconut, Peach Mango, Strawberry Kiwi | DIMETHICONE, OXYBENZONE, OCTINOXATE | The Mentholatum Company | 7c8a4921-ae45-47fb-a64e-c72b1a386d0d | 2024-12-17 | Warnings | M020 |
| Mentholatum Medicated Lip Balm Cherry | DIMETHICONE, OCTINOXATE, OCTISALATE | The Mentholatum Company | 6edb132d-bb67-4e6c-8e18-db0305073a71 | 2024-12-17 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85563-212-45 | 85563021245 | 4.5 g in 1 CYLINDER (85563-212-45) | 4.5 g | 2019-07-11 | No | No | Current |