Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk
- Product NDC
- 84803-104
- 11-digit product format
- 848030104
- Labeler code
- 84803
- Product ID
- 84803-104_5a0e9ed0-8900-f1b7-e063-6394a90abe9f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- spf50
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Grace And Fire USA Inc.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-12-01
- Substance
- OCTINOXATE; AVOBENZONE; OCTOCRYLENE
- Active strength
- 5; 3; 4.7 g/100g; g/100g; g/100g
- 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
- Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTINOXATE | 5 g/100g |
| AVOBENZONE | 3 g/100g |
| OCTOCRYLENE | 4.7 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4Y5P7MUD51 | Internal UNII lookup |
| G63QQF2NOX | Internal UNII lookup |
| 5A68WGF6WM | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2735ab0f-5eec-04c5-e063-6394a90aa60e | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84803-104-01 | Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk | 7 g in 1 TUBE | OINTMENT | 7 | 4 | |
| 84803-104-02 | Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk | 15 g in 1 TUBE | OINTMENT | 15 | 4 | |
| 84803-104-02 | ULTRA VIOLETTE SPF ON THE GLOWDuo Pack Kit | 15 g in 1 TUBE | OINTMENT | 1 g in 15 | 3 g in 100g | 4 |
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 |
|---|---|---|---|---|---|---|
| Simple Mineral Sunscreen SPF 50 | ZINC OXIDE | Simple Sunscreen LLC | c38cb4fa-8b8d-4c2d-9c32-301e120db1a1 | 2026-04-06 | Warnings | M020 |
| Badger SPF 50 Adventure Sport Mineral Sunscreen Cream | ZINC OXIDE | W.S. Badger Company, Inc. | 2a96c423-f4ad-0f07-e063-6394a90a39f8 | 2026-04-06 | Warnings | M020 |
| Sheer Touch Sunscreen SPF 55 | AVOBENZONE, HOMOSALATE, OCTISALATE | Amazon.com Services LLC | 03fce792-bcbb-4848-bc87-8913ecbe0786 | 2026-04-06 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | Amazon.com Services LLC | 8937705d-b745-4b8c-bf9b-89e64a1e52b1 | 2026-04-06 | Warnings, Adverse reactions | M020 |
| Avebonzone, Homosalate, Octisalate | AVEBONZONE, HOMOSALATE, OCTISALATE | Amazon.com Services LLC | 4ab6773f-00e1-897a-e063-6294a90ab0b8 | 2026-04-06 | Warnings, Adverse reactions | M020 |
| Principal Secret Revolutionary Anti-Aging Broad Spectrum SPF 15 | AVOBENZONE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENE | Guthy-Renker LLC | eb1a9b67-b9e2-41f8-bc6d-df94b6a33ab8 | 2026-04-06 | Warnings | M020 |
| TIRTIR HYDRO UV SHIELD SUNSCREEN SPF50 BROAD SPECTRUM | HOMOSALATE, AVOBENZONE, OCTISALATE, OCTOCRYLENE | TIRTIR USA Inc. | 4ec04105-e54f-a82e-e063-6394a90a6c5a | 2026-04-05 | Warnings | M020 |
| PRVWORA Ultra Defense Sunscreen | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Cellarkbio Inc. | 50cf1d88-3e7e-47b7-816a-3d579bde0a6a | 2026-04-04 | Warnings | M020 |
| EltaMD UV Shield SPF45 | ZINC OXIDE AND OCTINOXATE SUNSCREEN | CP Skin Health Group, Inc. | 7c49f971-d425-4be9-a665-5cd218b7f945 | 2026-04-03 | Warnings | M020 |
| Jack Black | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 4baade5c-e759-d98f-e063-6394a90aa056 | 2026-04-03 | Warnings | M020 |
| Vacation SPF 30 ClassicSpray | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Vacation Inc. | da43d71d-733b-5700-e053-2a95a90a5dca | 2026-04-03 | Warnings | M020 |
| Warriors Crown Sentinel Zinc Defense Sunscreen SPF 30 | ZINC OXIDE | Allure Labs | 4e93e64a-97ab-e0a5-e063-6294a90ad950 | 2026-04-03 | Warnings | M020 |
| Pro-Collagen Marine Broad Spectrum SPF 30 | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | ELEMIS Limited | 3321281e-612b-4305-bf6d-bfab02c65ffb | 2026-04-03 | Warnings | M020 |
| EltaMD Skincare UV AOX Elements SPF50 Tinted | TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 2c74209d-9b88-4c32-ad42-cd6de16c1fef | 2026-04-03 | Warnings | M020 |
| EltaMD UV Restore Tinted | TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 4fc18856-01b3-43ed-9e1b-b4394e31aa3c | 2026-04-03 | Warnings | M020 |
| Sunscreen for baby SPF50plus | OCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATE | Guangzhou Senmai Biotechnology Co., Ltd. | 1cb7fbca-0874-ae53-e063-6294a90ab42a | 2026-04-02 | Warnings | M020 |
| TiZO3 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | 4e7bdec2-abcc-0267-e063-6394a90ae47a | 2026-04-02 | Warnings | M020 |
| TIZO PHOTOCEUTICAL AM REPLENISH - TINTED | ZINC OXIDE | Fallien Cosmeceuticals, LTD | 4e7c4702-5707-6c3e-e063-6394a90a05fd | 2026-04-02 | Warnings | M020 |
| Ilia Sun Serum Mineral Sunscreen SPF 50 Light Medium | ZINC OXIDE | Ilia, Inc. | 4e7cc73c-d6c9-ecb0-e063-6394a90a922c | 2026-04-02 | Warnings | M020 |
| EltaMD UV Restore | TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 17b47994-82d6-4f9d-8249-bdb55106c9b3 | 2026-04-02 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 84803-104-01 | 84803010401 | 7 g in 1 TUBE (84803-104-01) | 7 g | 2024-12-01 | No | No | Current |
| 84803-104-02 | 84803010402 | 15 g in 1 TUBE (84803-104-02) | 15 g | 2024-12-01 | No | No | Current |