Softlips
- Product NDC
- 10742-8744
- 11-digit product format
- 107428744
- Labeler code
- 10742
- Product ID
- 10742-8744_2979d713-f1e4-980f-e063-6394a90acd5b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dimethicone, oxybenzone, octinoxate
- Dosage form
- STICK
- Route
- TOPICAL
- Labeler
- The Mentholatum Company
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-07-29
- Substance
- DIMETHICONE; OCTINOXATE; OXYBENZONE
- Active strength
- 20; 75; 40 mg/g; mg/g; mg/g
- Pharmacologic classes
- Skin Barrier Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Softlips
- Brand name suffix
- Oasis Pineapple Coconut, Peach Mango, Strawberry Kiwi
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIMETHICONE | 20 mg/g |
| OCTINOXATE | 75 mg/g |
| OXYBENZONE | 40 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 92RU3N3Y1O, 4Y5P7MUD51, 95OOS7VE0Y |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10742-8744-1 | SoftlipsOasis Pineapple Coconut, Peach Mango, Strawberry Kiwi | 4.5 g in 1 TUBE | STICK | 4.5 | | 3 |
| 10742-8744-1 | SoftlipsOasis Pineapple Coconut, Peach Mango, Strawberry Kiwi | 6 in 1 POUCH | STICK | 6 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10742-8744 | SOFTLIPS OASIS PINEAPPLE COCONUT, PEACH MANGO, STRAWBERRY KIWI (DIMETHICONE, OXYBENZONE, OCTINOXATE) STICK [THE MENTHOLATUM COMPANY] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241219_7c8a4921-ae45-47fb-a64e-c72b1a386d0d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 10742-8744-1 | 10742874401 | 6 TUBE in 1 POUCH (10742-8744-1) / 4.5 g in 1 TUBE | 6 tube | 2019-10-01 | 0000-00-00 | No | No | Current |