SPF 15 - Zinc Oxide Lip Balm
- Product NDC
- 63645-182
- 11-digit product format
- 636450182
- Labeler code
- 63645
- Product ID
- 63645-182_33657059-315e-02d5-e063-6294a90a6dcd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide
- Dosage form
- STICK
- Route
- TOPICAL
- Labeler
- OraLabs
- Application
- 352
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-06-06
- Substance
- ZINC OXIDE
- Active strength
- 100 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SPF 15 - Zinc Oxide Lip Balm
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZINC OXIDE | 100 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SOI2LOH54Z |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63645-182-01 | SPF 15 - Zinc Oxide Lip Balm | 4 g in 1 CONTAINER | STICK | 4 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63645-182 | SPF 15 - ZINC OXIDE LIP BALM (ZINC OXIDE) STICK [ORALABS] | 2 | Current NDC, 1 package rows | 20250424_8c293e38-83de-404a-b667-01c2e4b99072.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 63645-182-01 | 63645018201 | 4 g in 1 CONTAINER (63645-182-01) | 4 g | 2023-06-06 | No | No | Current |