SPF 45 - Lip Balm
- Product NDC
- 63645-183
- 11-digit product format
- 636450183
- Labeler code
- 63645
- Product ID
- 63645-183_3363a160-68b7-c576-e063-6294a90a8768
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Homosalate, Octinoxate, Octisalate, Petrolatum
- Dosage form
- STICK
- Route
- TOPICAL
- Labeler
- OraLabs
- Application
- 352
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-06-01
- Substance
- AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; PETROLATUM
- Active strength
- 30; 30; 75; 50; 400 mg/g; mg/g; 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
- SPF 45 - Lip Balm
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVOBENZONE | 30 mg/g |
| HOMOSALATE | 30 mg/g |
| OCTINOXATE | 75 mg/g |
| OCTISALATE | 50 mg/g |
| PETROLATUM | 400 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G63QQF2NOX, V06SV4M95S, 4Y5P7MUD51, 4X49Y0596W, 4T6H12BN9U |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63645-183-01 | SPF 45 - 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 |
|---|
| 63645-183 | SPF 45 - LIP BALM (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUM) STICK [ORALABS] | 2 | Current NDC, 1 package rows | 20250424_afd10abe-1e8b-4df8-9d8c-ef15266c510c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 63645-183-01 | 63645018301 | 4 g in 1 CONTAINER (63645-183-01) | 4 g | 2023-06-01 | No | No | Current |