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 |
|---|---|---|---|---|---|---|
| SHISEIDO BENEFIANCE WRINKLERESIST24 DAY | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | 7d9c0f81-005f-4223-940e-a64143db5275 | 2026-01-06 | Warnings | M020 |
| SHISEIDO FUTURE Solution LX INFINITE TREATMENT PRIMER | TITANIUM DIOXIDE, OCTINOXATE, AND ENSULIZOLE | SHISEIDO AMERICAS CORPORATION | ff088b0c-27c9-4ea8-bf94-6261378c7190 | 2026-01-06 | Warnings | M020 |
| Drs. pharmacy sunscreen SPF 50 (physical filters) | SUNSCREEN SPF 50 | OL PHARMA TECH LLC. (Drs. Pharmacy) | 31e976a2-0623-0dca-e063-6394a90a08da | 2026-01-06 | Warnings | M020 |
| SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 Fair Shirakaba | OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 26151cf4-0fee-4a42-92fd-4d7b9cef8381 | 2026-01-06 | Warnings | M020 |
| Drs. pharmacy sunscreen SPF 50 (physical filters) | SUNSCREEN SPF 50 | OL PHARMA TECH LLC. (Drs. Pharmacy) | 315a5ca4-4536-d585-e063-6294a90a1c50 | 2026-01-06 | Warnings | M020 |
| Drs. pharmacy sunscreen SPF 30 (Physical Filters) | SUNSCREEN SPF 30 | OL PHARMA TECH LLC. (Drs. Pharmacy) | 315a5b1f-9dc2-a243-e063-6394a90a5e08 | 2026-01-06 | Warnings | M020 |
| SHISEIDO ULTIMATE SUN PROTECTOR | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | 51f759b7-8c49-41d4-aaa3-f901d599cac5 | 2026-01-06 | Warnings | M020 |
| cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n (Refill) | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | 463dc557-9743-4a38-969e-2c78fc10ee2a | 2026-01-06 | Warnings | M020 |
| CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE | SHISEIDO AMERICAS CORPORATION | 23bb4225-bfb5-47e2-80fe-733761ba4069 | 2026-01-06 | Warnings | M020 |
| SHISEIDO WHITE LUCENT DAY | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | e881e637-e0f0-4c90-8343-2be6e74020b8 | 2026-01-06 | Warnings | M020 |
| Hawaiian Tropic Lip Balm Sunscreen SPF 30 | AVOBENZONE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | c7b71be3-f906-bd09-e053-2995a90adc61 | 2026-01-06 | Warnings | M020 |
| SHISEIDO BENEFIANCE WRINKLERESIST24 DAY | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | d308d578-c881-4c10-8c79-9e3cd58b694c | 2026-01-06 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 051b7413-8f1b-7135-e063-6294a90a9364 | 2026-01-06 | Warnings | M020 |
| Coppertone Sport Sunscreen Lip Balm SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, | Beiersdorf Inc | 47bc6776-1130-0162-e063-6294a90a2adc | 2026-01-06 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 088fa3cd-b9b8-d10b-e063-6394a90a7fd6 | 2026-01-06 | Warnings | M020 |
| SPF 50 Florida Sun Defense Broad Spectrum SPF 50 Sunscreen Body Oil | HOMOSALATE, OCTISALATE, OCTOCRYLENE | Naples Soap Company, Inc. | 47c147a9-c4f4-ab82-e063-6394a90aaa5c | 2026-01-06 | Warnings | M020 |
| PoutScreen Lip Treatment Love Letter | AVOBENZONE, OCTINOXATE, OCTOCRYLENE | NAKED SUNDAYS PTY LTD | 47d22c6d-49fd-f97c-e063-6294a90a6ba1 | 2026-01-06 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands, LLC | 56ab90db-51bd-ffb3-e063-6294a90a852b | 2026-01-06 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands, LLC | 56ac28e7-41f1-bd4e-e063-6294a90a0e7b | 2026-01-06 | Warnings | M020 |
| Moisturizing Antioxidant SPF 50 | OCTINOXATE, OCTISALATE, HOMOSALATE, OXYBENZONE, ZINC OXIDE | Topiderm, Inc. | 727c14d3-ad26-4e8b-91f6-b7a5f07e4e2f | 2026-01-05 | 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 |