ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM
- Product NDC
- 84616-007
- 11-digit product format
- 846160007
- Labeler code
- 84616
- Product ID
- 84616-007_4fea1efd-c18a-817f-e063-6294a90a8afb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Homosalate, Octisalate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- SEORIN COMPANY Co., Ltd.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-09-18
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE
- Active strength
- 2.7; 13.5; 4.5 g/100mL; g/100mL; g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVOBENZONE | 2.7 g/100mL |
| HOMOSALATE | 13.5 g/100mL |
| OCTISALATE | 4.5 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G63QQF2NOX, V06SV4M95S, 4X49Y0596W |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84616-007-01 | ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM | 50 mL in 1 TUBE | CREAM | 50 | | 5 |
| 84616-007-02 | ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM | 10 mL in 1 TUBE | CREAM | 10 | | 5 |
| 84616-007-03 | ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM | 2 in 1 BOX | CREAM | 2 | | 5 |
| 84616-007-04 | ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM | 60 mL in 1 TUBE | CREAM | 60 | | 5 |
| 84616-007-05 | ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM | 30 mL in 1 TUBE | CREAM | 30 | | 5 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84616-007-01 | 84616000701 | 50 mL in 1 TUBE (84616-007-01) | 50 ml | 2024-09-18 | No | No | Current |
| 84616-007-02 | 84616000702 | 10 mL in 1 TUBE (84616-007-02) | 10 ml | 2024-12-18 | No | No | Current |
| 84616-007-03 | 84616000703 | 2 TUBE in 1 BOX (84616-007-03) / 60 mL in 1 TUBE (84616-007-04) | 2 tube | 2024-12-20 | No | No | Current |
| 84616-007-04 | 84616000704 | 60 mL in 1 TUBE | 60 ml | | | | Historical |
| 84616-007-05 | 84616000705 | 30 mL in 1 TUBE (84616-007-05) | 30 ml | 2026-04-20 | No | No | Current |