EIGHT HOUR LIP PROTECTANT SPF 15
- Product NDC
- 10967-692
- 11-digit product format
- 109670692
- Labeler code
- 10967
- Product ID
- 10967-692_2a0ac71c-e567-5ff9-e063-6394a90a4807
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONE
- Dosage form
- LIPSTICK
- Route
- TOPICAL
- Labeler
- REVLON
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-11-01
- Substance
- AVOBENZONE; OCTINOXATE; OXYBENZONE; PETROLATUM
- Active strength
- 2; 7.49475; 3; 30.99938 mg/g; mg/g; mg/g; mg/g
- 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
- EIGHT HOUR LIP PROTECTANT SPF 15
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AVOBENZONE | 2 mg/g |
| OCTINOXATE | 7.49475 mg/g |
| OXYBENZONE | 3 mg/g |
| PETROLATUM | 30.99938 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| G63QQF2NOX | Internal UNII lookup |
| 4Y5P7MUD51 | Internal UNII lookup |
| 95OOS7VE0Y | Internal UNII lookup |
| 4T6H12BN9U | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2a0ac6aa-0315-d79e-e063-6294a90a9c53 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10967-692-61 | EIGHT HOUR LIP PROTECTANT SPF 15 | 3.7 g in 1 CARTRIDGE | LIPSTICK | 3.7 | 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 |
|---|---|---|---|---|---|---|
| Intensive Age Defying Hydrating Complex SPF 25 | HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE | June Jacobs Labs, LLC | 18f59d9d-1328-d815-e063-6294a90a3801 | 2024-05-21 | Warnings | M020 |
| Advanced Sun Resistance SPF 30 | HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE | June Jacobs Labs, LLC | 18f879f0-3d5b-0067-e063-6394a90a9db3 | 2024-05-21 | Warnings | M020 |
| Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | June Jacobs Labs LLC | 18e1edd9-e39b-c91f-e063-6394a90a32a0 | 2024-05-20 | Warnings | M020 |
| Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | June Jacobs Labs, LLC | 18e4c50d-eb91-c269-e063-6394a90a7999 | 2024-05-20 | Warnings | M020 |
| Broad Spectrum SPF 30 Tropical Sunscreen | BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN | Raining Rose, Inc | 18e7fc6b-b40a-f790-e063-6294a90ad0f4 | 2024-05-20 | Warnings | M020 |
| Protectif Untinted | ZINC OXIDE AND TITANIUM DIOXIDE | Allure Labs | 18aa2604-c8f0-ca04-e063-6294a90a1c25 | 2024-05-17 | Warnings | M020 |
| Vacation Shimmer Oil | AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE | Vacation Inc | 150cbb23-fcb9-ed6f-e063-6394a90a597c | 2024-05-16 | Warnings | M020 |
| Babo Botanicals Daily Sheer Fluid Tinted Mineral Sunscreen SPF 50 | ZINC OXIDE | Babo Botanicals, Inc. | d66dfcec-ad40-3a0b-e053-2995a90aa006 | 2024-05-14 | Warnings | M020 |
| Babo Botanicals Daily Sheer Fluid Mineral Sunscreen SPF 50 | ZINC OXIDE | Babo Botanicals, Inc. | d66c88a1-7684-1043-e053-2a95a90aa2aa | 2024-05-14 | Warnings | M020 |
| Jack Black | TITANIUM DIOXIDE, ZINC OXIDE | Jack Black L.L.C | 181d5bf3-ce91-cb2c-e063-6294a90a51c4 | 2024-05-10 | Warnings | M020 |
| Protectif Fair Tint | ZINC OXIDE AND TITANIUM DIOXIDE | Allure Labs | 181e3f34-c5b2-0976-e063-6394a90a9a78 | 2024-05-10 | Warnings | M020 |
| SABIYA Broad Spectrum SPF-30 | ZINC OXIDE | SABIYA, LLC | bc403672-7576-49a6-9a29-4f6cb19af7a4 | 2024-05-09 | Warnings | M020 |
| SABIYA Broad Spectrum SPF-50 | ZINC OXIDE | SABIYA, LLC | 4264f23f-4f2a-4fd1-ad35-e7d649ee3f5c | 2024-05-09 | Warnings | M020 |
| Protectif Deep Tint | ZINC OXIDE AND TITANIUM DIOXIDE | Allure Labs | 180b2939-5ae4-88fb-e063-6394a90aad93 | 2024-05-09 | Warnings | M020 |
| UV Daily Deep Tint | OCTINOXATE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc. | c12fa9a4-d7e5-46bf-9bfb-1cbbaa73b450 | 2024-05-09 | Warnings | M020 |
| Chemical Sunscreen SPF50 | OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE SUNSCREEN | Swiss-American CDMO, LLC | 50f47495-93aa-4e11-a153-d4c847a36c99 | 2024-05-08 | Warnings | M020 |
| UV Clear Deep Tint | OCTINOXATE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc. | ead07d51-9400-4f0a-8966-7052dfae67bc | 2024-05-08 | Warnings | M020 |
| Essence Pout Protector SPF 20 Lip Balm | HOMOSALATE, OCTISALATE, ZINC OXIDE | cosnova GmbH | 17e483c5-6e47-9a50-e063-6394a90aa604 | 2024-05-07 | Warnings, Adverse reactions | M020 |
| MIRABELLA Broad Spectrum SPF 30 Sunscreen | HOMOSALATE, OCTISALATE, AVOBENZONE | GDM ENTERPRISES LLC | 3ac847d5-a75d-4b32-84e1-70e4282c0d72 | 2024-05-06 | Warnings | M020 |
| MELAN SPF-30 Broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE | MELAN INC. | 75fcef12-bc33-44a7-acda-77d5d7bca2bc | 2024-05-02 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 10967-692-61 | 10967069261 | 3.7 g in 1 CARTRIDGE (10967-692-61) | 3.7 g | 2021-11-01 | No | No | Current |