Tinted Lip Cream SPF 15
- Product NDC
- 68577-168
- 11-digit product format
- 685770168
- Labeler code
- 68577
- Product ID
- 68577-168_29227121-e57a-8eea-e063-6394a90a302f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ZINC OXIDE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- COSMAX USA, CORPORATION
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-01-01
- Substance
- ZINC OXIDE
- Active strength
- 9.28 mg/100mg
- 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 Lip Cream SPF 15
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 9.28 mg/100mg |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 29227121-e579-8eea-e063-6394a90a302f | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68577-168-01 | Tinted Lip Cream SPF 15 | 1 in 1 CARTON | CREAM | 1 | 1 | |
| 68577-168-01 | Tinted Lip Cream SPF 15 | 17 mg in 1 TUBE, WITH APPLICATOR | CREAM | 17 | 1 |
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 |
|---|---|---|---|---|---|---|
| Sei Bella Tinted BB Moisturizing Creme Medium to Deep 450 W | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | 68e30255-564f-3b4a-e053-2991aa0ab3f7 | 2025-12-31 | Warnings | M020 |
| Sei Bella Tinted BB Moisturizing Creme Medium 320 C | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | 68e2e541-c596-0f12-e053-2991aa0a4ab2 | 2025-12-31 | Warnings | M020 |
| Sei Bella Tinted BB Moisturizing Creme Light to Medium 160 N | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | 68e20c57-7b30-4e96-e053-2991aa0aab3e | 2025-12-31 | Warnings | M020 |
| Sun Shades Lip Balm Pina Colada | AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% | Melaleuca Inc. | 16d0d2d2-b9c4-4491-8d8a-815843d342e8 | 2025-12-31 | Warnings | M020 |
| Sun Shades Lip Balm Mountain Mint | AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% | Melaleuca Inc. | 326d9623-0e67-43bd-83f8-ee7dfa3bdbe8 | 2025-12-31 | Warnings | M020 |
| Sun Shades Lip Balm Vanilla Bean | AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% | Melaleuca Inc. | 2037cc9d-b11b-47d6-8d65-c0f9decc8ba7 | 2025-12-31 | Warnings | M020 |
| Sun Shades Mineral Plus Sunscreen with Zinc Oxide | OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5% | Melaleuca Inc. | 8886cbd0-ed2b-4a2b-a724-a0d4f12296c9 | 2025-12-31 | Warnings | M020 |
| Eucerin Daily Hydration | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | 798cbf7f-b93d-49c8-b1c1-216486e57ea5 | 2025-12-31 | Warnings | M020 |
| Eucerin Face immersive Hydration | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | fe0b3717-f472-3a61-e053-6394a90a44fb | 2025-12-31 | Warnings | M020 |
| NIVEA MEN Age Defense Face Moisturizer | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | 27cbec3e-e811-6498-e063-6394a90ada49 | 2025-12-31 | Warnings | M020 |
| Nivea Men Maximum Hydration Face | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | f1276b11-6683-e982-e053-2a95a90a7803 | 2025-12-31 | Warnings | M020 |
| Nivea Men Sensitive Protective | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | f6cff3d1-cca5-4b3e-a481-0c4def90684c | 2025-12-31 | Warnings | M020 |
| Nivea Smoothness Lip Care | AVOBENZONE,OCTOCRYLENE | Beiersdorf Inc | c28e327d-ad39-9bd6-e053-2a95a90a04eb | 2025-12-31 | Warnings | M020 |
| BOTANICAL SOOTHING SPF-30 | OCTINOXATE, OCTISALATE, ZINC OXIDE | CONTROL CORRECTIVE SKINCARE INC | 00a923fe-e6da-420e-a705-4773ecc2176b | 2025-12-31 | Warnings | M020 |
| AROMA MATTE DAY SUNSCREEN SPF-30 | OCTINOXATE, OCTISALATE, ZINC OXIDE | CONTROL CORRECTIVE SKINCARE INC | f822f3ec-3c57-100a-e053-6294a90ab0ec | 2025-12-31 | Warnings | M020 |
| CONTROL CORRECTIVE TINTED MOISTURIZER SPF-30 SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | CONTROL CORRECTIVE SKINCARE INC | 8ac09149-f7e7-40a8-b306-98964d0cd6e3 | 2025-12-31 | Warnings | M020 |
| CONTROL CORRECTIVE SUNSCREEN SPF-30 | OCTINOXATE, OCTISALATE, ZINC OXIDE | CONTROL CORRECTIVE SKINCARE INC | e389b2bc-bb1c-443a-9bf6-c6d96380f378 | 2025-12-31 | Warnings | M020 |
| CONTROL CORRECTIVE INTENSIVE SKIN BRIGHTENING SPF-30 SUNSCREEN | OCTINOXATE, OCTISALATE, ZINC OXIDE | CONTROL CORRECTIVE SKINCARE INC | 61b6dab9-3378-4206-bf1f-6f385a9c882c | 2025-12-31 | Warnings | M020 |
| Blue Lizard Sensitive SPF 50 Sunscreen | TITANIUM DIOXIDE AND ZINC OXIDE | Crown Laboratories | 32d78048-d281-1d80-e063-6394a90aec19 | 2025-12-31 | Warnings | M020 |
| DAYWEAR ANTI OXIDANT 72H-HYDRATION SORBET CREME BROAD SPECTRUM SPF 15 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | ESTEE LAUDER INC | df535004-c94c-4a28-ad20-78bd1741e39f | 2025-12-31 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 68577-168-01 | 68577016801 | 1 TUBE, WITH APPLICATOR in 1 CARTON (68577-168-01) / 17 mg in 1 TUBE, WITH APPLICATOR | 2024-01-01 | No | No | Current |