Sunscreen
- Product NDC
- 61354-047
- Requested package NDC
- 61354-047-03
- 11-digit product format
- 613540047
- Labeler code
- 61354
- Product ID
- 61354-047_d7fe4990-507f-4062-e053-2a95a90ae6d9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Homosalate, Octocrylene, Octisalate, Avobenzone
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Oxygen Development, LLC
- Application
- part352
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-02-14
- Marketing end
- 0000-00-00
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
- Active strength
- 3 mg/100mg; mg/100mg; mg/100mg; mg/100mg
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61354-047-01 | Sunscreen | 100 mg in 1 TUBE | GEL | 100 | | 2 |
| 61354-047-02 | Sunscreen | 1 in 1 PACKAGE | GEL | 1 | | 2 |
| 61354-047-03 | Sunscreen | 1 in 1 CARTON | GEL | 1 | | 2 |
| 61354-047-04 | Sunscreen | 1 in 1 PACKAGE | GEL | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61354-047 | SUNSCREEN (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) GEL [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 4 package rows | 20230204_d7fe4990-507e-4062-e053-2a95a90ae6d9.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61354-047-03 | 61354004703 | 1 PACKAGE in 1 CARTON (61354-047-03) > 1 TUBE in 1 PACKAGE (61354-047-02) > 100 mg in 1 TUBE (61354-047-01) | 1 package | 2022-02-14 | 0000-00-00 | No | No | Current |