Total Eye 3-In-1 Renewal Therapy SPF 35
- Product NDC
- 68078-024
- 11-digit product format
- 680780024
- Labeler code
- 68078
- Product ID
- 68078-024_9f51cd1f-3c72-44f7-aea4-61bdf449737b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide and Zinc Oxide
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Colorescience
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-01-19
- Substance
- TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 79; 67 mg/mL; mg/mL
- 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
- Total Eye 3-In-1 Renewal Therapy SPF 35
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TITANIUM DIOXIDE | 79 mg/mL |
| ZINC OXIDE | 67 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
| 15FIX9V2JP | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4b116cc4-94d2-4bfc-b7f9-5f486a194c6c | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d1c9d1af-bddd-448d-86f7-69052b7d5b47 | Product name | 1 | 20220627 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 68078-024-01 | 2021-12-20 | Total Eye™ 3-In-1 Renewal Therapy SPF 35 |
| 68078-024-02 | 2021-12-20 | Total Eye™ 3-In-1 Renewal Therapy SPF 35 |
| 68078-024-01 | 2021-01-29 | Total Eye™ 3-In-1 Renewal Therapy SPF 35 |
| 68078-024-02 | 2021-01-29 | Total Eye™ 3-In-1 Renewal Therapy SPF 35 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68078-024-01 | Total Eye 3-In-1 Renewal Therapy SPF 35 | 7 mL in 1 TUBE | LIQUID | 7 | 6 | |
| 68078-024-01 | Total Eye 3-In-1 Renewal Therapy SPF 35 | 1 in 1 CARTON | LIQUID | 1 | 6 | |
| 68078-024-02 | Total Eye 3-In-1 Renewal Therapy SPF 35 | 0.5 mL in 1 PACKET | LIQUID | 0.5 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68078-024 | TOTAL EYE 3-IN-1 RENEWAL THERAPY SPF 35 (TITANIUM DIOXIDE AND ZINC OXIDE) LIQUID TOTAL EYE 3-IN-1 RENEWAL THERAPY SPF 35 (FAIR) (TITANIUM DIOXIDE AND ZINC OXIDE) LIQUID TOTAL EYE 3-IN-1 RENEWAL THERAPY SPF 35 (TAN) (TITANIUM DIOXIDE AND ZINC OXIDE) LIQUID TOTAL EYE 3-IN-1 RENEWAL THERAPY SPF 35 (DEEP) (TITANIUM DIOXIDE AND ZINC OXIDE) LIQUID [COLORESCIENCE] | 4 | Current NDC, Legacy NDC, 3 package rows | 20231216_4b116cc4-94d2-4bfc-b7f9-5f486a194c6c.zip |
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 |
|---|---|---|---|---|---|---|
| Banana Boat Ultra Sport Sunscreen Broad Spectrum SPF 15 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands, LLC | 9751a700-5d51-357b-e053-2a95a90af66c | 2024-10-27 | Warnings | M020 |
| Banana Boat Sport Ultra Face SPF30 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | dc757b03-7e7d-b362-e053-2a95a90a8446 | 2024-10-27 | Warnings | M020 |
| Banana Boat Kids Mineral Protection SPF50 | TITANIUM DIOXIDE,ZINC OXIDE | Edgewell Personal Care Brands LLC | dc7701b5-0c73-b4df-e053-2a95a90a0f1b | 2024-10-27 | Warnings | M020 |
| Banana Boat Mineral Sensitive SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Edgewell Personal Care Brands LLC | dc7913d5-58f2-3077-e053-2a95a90a1627 | 2024-10-27 | Warnings | M020 |
| BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | e5f9d56d-a80e-221c-e053-2a95a90aae92 | 2024-10-27 | Warnings | M020 |
| Banana Boat Mineral Sensitive Face SPF50 | TITANIUM DIOXIDE, ZINC OXIDE | Edgewell Personal Care Brands LLC | dc783438-b28f-b7f4-e053-2a95a90a3d65 | 2024-10-27 | Warnings | M020 |
| BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | e53509bf-6bb7-2db7-e053-2a95a90aae18 | 2024-10-27 | Warnings | M020 |
| Banana Boat Sport Mineral SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Edgewell Personal Care Brands LLC | dc79790f-e2bc-5414-e053-2a95a90a9e7a | 2024-10-27 | Warnings | M020 |
| TiZO Mineral Stick - Tinted SPF 45 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | fd6d0080-0bef-4e7e-8ca5-b859639efd0c | 2024-10-25 | Warnings | M020 |
| Alumier MD Post Procedure Kit with Hydrocortisone | TITANIUM DIOXIDE, ZINC OXIDE, HYDROCORTISONE | Alumier Labs | 2551d748-c3d6-cd18-e063-6294a90adab6 | 2024-10-25 | Warnings | M020 |
| TiZO Mineral Stick Non-Tinted SPF 45 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | e7044f18-992a-4f60-9a2b-f11ed06db09b | 2024-10-25 | Warnings | M020 |
| CoTZ Lip Balm | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | 479a7d82-a068-4c2e-b50b-555c40e13e37 | 2024-10-25 | Warnings | M020 |
| TiZO Mineral Sun Defense SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals Ltd. | e17a8c35-2d49-4c99-b154-ea673c14753e | 2024-10-25 | Warnings | M020 |
| IPKN Moist and Firm Beauty Balm Light Medium | TITANIUM DIOXIDE | Inel Cosmetics Co., Ltd. | 1af6184e-3dc4-4eb3-8d51-aca724473451 | 2024-10-25 | Warnings | M020 |
| IPKN Moist and Firm Beauty Balm Light | TITANIUM DIOXIDE | Inel Cosmetics Co., Ltd. | 77d77838-aa13-4939-a1a0-50189fbb3fe0 | 2024-10-25 | Warnings | M020 |
| Dove Men plus Care Hydrate Face | AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE | CONOPCO Inc. d/b/a Unilever | afe75aff-c056-eaf7-e053-2a95a90af71b | 2024-10-24 | Warnings | M020 |
| Cancer Council Mineral Fluid SPF50 | ZINC OXIDE | Vitality US Co. | 1638f8a4-a2da-4e1f-e063-6294a90a03d9 | 2024-10-24 | Warnings | M020 |
| Marlowe SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Marlowe Holdings, LLC | f94bd91a-f0ab-680c-e053-6394a90ac855 | 2024-10-23 | Warnings | M020 |
| Vacation Broad Spectrum SPF 30 | HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE | Vacation Inc. | 2526eadf-4b55-ff81-e063-6394a90a3ba7 | 2024-10-23 | Warnings | M020 |
| Tenacious Ergodyne | KREWD CLEAR SPF 50 CONTINUOUS SPRAY | Tenacious Holdings, Inc. | 55d99d0a-dc7f-4915-b7c1-f999c8b36e0d | 2024-10-23 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68078-024-01 | 68078002401 | 1 TUBE in 1 CARTON (68078-024-01) / 7 mL in 1 TUBE | 1 tube | 2018-01-19 | 0000-00-00 | No | No | Current |
| 68078-024-02 | 68078002402 | .5 mL in 1 PACKET (68078-024-02) | 2018-01-19 | 0000-00-00 | No | No | Current |