Leader
- Product NDC
- 70000-0535
- 11-digit product format
- 700000535
- Labeler code
- 70000
- Product ID
- 70000-0535_44fc8e0e-6b09-d5c7-e063-6394a90a8467
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- avobenzone, homosalate, octisalate, octocrylene, oxybenzone
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- CARDINAL HEALTH, INC.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-12-03
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
- Active strength
- 30; 150; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Leader
- Brand name suffix
- Ultra Sheer SPF 100 Sunscreen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVOBENZONE | 30 mg/mL |
| HOMOSALATE | 150 mg/mL |
| OCTISALATE | 50 mg/mL |
| OCTOCRYLENE | 100 mg/mL |
| OXYBENZONE | 60 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM, 95OOS7VE0Y |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70000-0535-1 | LeaderUltra Sheer SPF 100 Sunscreen | 89 mL in 1 TUBE | LOTION | 89 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70000-0535 | LEADER ULTRA SHEER SPF 100 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [CARDINAL HEALTH, INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241024_b5a467e0-a6ab-4136-8101-f22cc319de58.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70000-0535-1 | 70000053501 | 89 mL in 1 TUBE (70000-0535-1) | 89 ml | 2019-12-03 | 0000-00-00 | No | No | Current |