Sunfrog Ultra SPF 30 Lip Balm
- Product NDC
- 63645-165
- 11-digit product format
- 636450165
- Labeler code
- 63645
- Product ID
- 63645-165_3406aff4-68b5-4934-e063-6394a90aa85c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Octinoxate, Octocrylene, Oxybenzone, Octisalate, Petroleum Jelly
- Dosage form
- STICK
- Route
- TOPICAL
- Labeler
- OraLabs
- Application
- 352
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-11-29
- Substance
- OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; PETROLATUM
- Active strength
- 7.5; 5; 7; 5; 30 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
- Sunfrog Ultra SPF 30 Lip Balm
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OCTINOXATE | 7.5 mg/g |
| OCTISALATE | 5 mg/g |
| OCTOCRYLENE | 7 mg/g |
| OXYBENZONE | 5 mg/g |
| PETROLATUM | 30 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4Y5P7MUD51, 4X49Y0596W, 5A68WGF6WM, 95OOS7VE0Y, 4T6H12BN9U |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63645-165-01 | Sunfrog Ultra SPF 30 Lip Balm | 1 g in 1 CONTAINER | STICK | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63645-165 | SUNFROG ULTRA SPF 30 LIP BALM (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, PETROLEUM JELLY) STICK [ORALABS] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250502_61299626-bf60-40e8-a2d3-4d4a99d8d15c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63645-165-01 | 63645016501 | 1 g in 1 CONTAINER (63645-165-01) | 1 g | 2017-11-29 | 0000-00-00 | No | No | Current |