5299 SUNSCREEN
- Product NDC
- 76138-221
- 11-digit product format
- 761380221
- Labeler code
- 76138
- Product ID
- 76138-221_5f020bbb-634a-560e-e063-6394a90aed9b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Homosalate, Octocrylene, Octisalate
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Innovation Specialties
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-05-10
- Substance
- AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
- Active strength
- 30; 100; 100; 50 mg/mL; mg/mL; mg/mL; mg/mL
- 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
- 5299 SUNSCREEN
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AVOBENZONE | 30 mg/mL |
| HOMOSALATE | 100 mg/mL |
| OCTOCRYLENE | 100 mg/mL |
| OCTISALATE | 50 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| G63QQF2NOX | Internal UNII lookup |
| V06SV4M95S | Internal UNII lookup |
| 5A68WGF6WM | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f3db6bd8-cc6f-4af5-809d-95fb05f6732f | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76138-221-06 | 2024-01-30 | C162847 | 48780-1 | 1030e364-ff02-111a-e063-dadaa90a10e2 | 5299 SUNSCREEN |
| 76138-221-06 | 2024-01-30 | C162847 | 48780-1 | 1030e364-ff02-111a-e063-dadaa90a10e2 | 5299 SUNSCREEN |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76138-221-06 | 5299 SUNSCREEN | 20 mL in 1 BOTTLE | LOTION | 20 | 3 |
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 |
|---|---|---|---|---|---|---|
| Refreshing Water Hydration Stick SPF 50 | AVOBENZONE OCTISALATE HOMOSALATE OCTOCRYLENE | COOLA LLC | 6da037f8-bedb-467a-b534-e44752120f2c | 2024-12-27 | Warnings | M020 |
| Nu Skin ageLOC Radiant Day Broad Spectrum SPF 22 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | NSE Products, Inc. | 649a9c28-bfd4-404c-90d5-5d0ea8c7b645 | 2024-12-27 | Warnings | M020 |
| Kiehls Since 1851 Activated Sun Protector For Face and Body Broad Spectrum SPF 50 Sunscreen | TITANIUM DIOXIDE | L'Oreal USA Products Inc | 87496037-36ca-4c5f-973f-46626cf4096e | 2024-12-27 | Warnings | M020 |
| PORESCREEN SPF40 | ZINC OXIDE | Dermalogica, LLC. | 37a7362a-b251-4d3a-a957-65d8f338fa12 | 2024-12-27 | Warnings | M020 |
| COOLA Classic Face Sunscreen Fragrance-Free SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | COOLA LLC | 12ff4689-f7e2-49db-8848-608c61b41ef0 | 2024-12-27 | Warnings | M020 |
| NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINT | ZINC OXIDE | Bentley Laboratories, LLC | 6edd51e5-1c42-4e66-b5ca-abfea2dad8f8 | 2024-12-27 | Warnings | M020 |
| Tone Control Morning Cream SPF 15 | OCTOCRYLENE AND OCTISALATE CREAM | Bentley Laboratories, LLC | b4e3cd1c-ae42-4995-a314-96d24d328e41 | 2024-12-27 | Warnings | M020 |
| ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light) | ZINC OXIDE | ZO Skin Health, Inc. | be25489e-c3bf-77c5-e053-2a95a90a30de | 2024-12-27 | Warnings | M020 |
| COOLA Classic Body Sunscreen Tropical Coconut SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | COOLA LLC | 55ad5d2f-a855-491e-a287-13689f8abff1 | 2024-12-27 | Warnings | M020 |
| RODAN and FIELDS UNBLEMISH | TITANIUM DIOXIDE, ZINC OXIDE | Bentley Laboratories, LLC | 2b3b6b62-364f-4aba-8024-3a73752b4c56 | 2024-12-27 | Warnings | M020 |
| Powerbright Moisturizer SPF 50 | OCTOCRYLENE, HOMOSALATE, AVOBENZONE, AND OCTISALATE | Dermalogica, LLC. | 02c731ee-c5cb-4158-9b1f-e826593c3526 | 2024-12-27 | Warnings | M020 |
| INVISIBLE PHYSICAL DEFENSE SPF30 | ZINC OXIDE | Dermalogica, Inc. | 2e5e6861-25ea-4605-8e59-41d852c002b7 | 2024-12-27 | Warnings | M020 |
| COOLA CLASSIC FACE SUNSCREEN Cucumber Broad Spectrum SPF 30 | AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE | COOLA LLC | dec3b0d1-f06e-4acf-8ba2-64167e774abc | 2024-12-27 | Warnings | M020 |
| Clearing Defense SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Dermalogica, Inc. | 2388ae53-0a61-43c0-8936-c639887a5649 | 2024-12-26 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c5efde-42e3-e4fc-e063-6394a90a491d | 2024-12-26 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c62206-d832-8d9a-e063-6394a90a4c69 | 2024-12-26 | Warnings | M020 |
| Morphe SPF 30 Broad Spectrum Sunsetter Setting | OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE | COSMAX USA, CORPORATION | 0d34406f-9dd0-3909-e063-6394a90ab9f9 | 2024-12-26 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c64cc0-be42-c210-e063-6394a90a6d9a | 2024-12-26 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c61c42-edda-1ebd-e063-6294a90aee13 | 2024-12-26 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c62206-d839-8d9a-e063-6394a90a4c69 | 2024-12-26 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 76138-221-06 | 76138022106 | 20 mL in 1 BOTTLE (76138-221-06) | 20 ml | 2022-05-10 | 0000-00-00 | No | No | Current |