OS-01 Lip SPF BS SPF15
- Product NDC
- 84451-004
- 11-digit product format
- 844510004
- Labeler code
- 84451
- Product ID
- 84451-004_351d69f9-5ae2-1dec-e063-6294a90ad7a1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- ONESKIN INC.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-05-07
- Substance
- ZINC OXIDE
- Active strength
- 5.5 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OS-01 Lip SPF BS SPF15
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZINC OXIDE | 5.5 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SOI2LOH54Z |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84451-004-01 | OS-01 Lip SPF BS SPF15 | 12 g in 1 TUBE | CREAM | 12 | | 1 |
| 84451-004-02 | OS-01 Lip SPF BS SPF15 | 1 in 1 CARTON | CREAM | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 84451-004 | OS-01 LIP SPF BS SPF15 (ZINC OXIDE) CREAM [ONESKIN INC.] | 1 | Current NDC, 2 package rows | 20250515_351d55f6-fcd9-1d47-e063-6294a90a2cf0.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84451-004-01 | 84451000401 | 12 g in 1 TUBE | 12 g | | | | Historical |
| 84451-004-02 | 84451000402 | 1 TUBE in 1 CARTON (84451-004-02) / 12 g in 1 TUBE (84451-004-01) | 1 tube | 2025-05-07 | No | No | Current |