OraLabs SPF 15 Lip Balm
- Product NDC
- 63645-181
- 11-digit product format
- 636450181
- Labeler code
- 63645
- Product ID
- 63645-181_3365a012-e546-2e6f-e063-6394a90ab1fb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Octinoxate, Petrolatum
- Dosage form
- STICK
- Route
- TOPICAL
- Labeler
- OraLabs
- Application
- 352
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-06-20
- Substance
- AVOBENZONE; OCTINOXATE; PETROLATUM
- Active strength
- 30; 75; 423 mg/g; mg/g; 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
- OraLabs SPF 15 Lip Balm
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVOBENZONE | 30 mg/g |
| OCTINOXATE | 75 mg/g |
| PETROLATUM | 423 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G63QQF2NOX, 4Y5P7MUD51, 4T6H12BN9U |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63645-181-03 | OraLabs SPF 15 Lip Balm | 4.25 g in 1 CONTAINER | STICK | 4.25 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63645-181 | ORALABS SPF 15 LIP BALM (AVOBENZONE, OCTINOXATE, PETROLATUM) STICK [ORALABS] | 2 | Current NDC, Legacy NDC, 1 package rows | 20250424_3ac8569f-4b11-4536-8919-234f79bbd7fc.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63645-181-03 | 63645018103 | 4.25 g in 1 CONTAINER (63645-181-03) | 4.25 g | 2022-06-20 | 0000-00-00 | No | No | Current |