Safe Sea SPF 50
- Product NDC
- 65435-0100
- 11-digit product format
- 654350100
- Labeler code
- 65435
- Product ID
- 65435-0100_45849749-2d41-84a5-e063-6394a90acdbe
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Homosalate, Octocrylene, Octisalate, Avobenzone
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- NIDARIA TECHNOLOGY LTD
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-04-30
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
- Active strength
- 30; 100; 50; 100 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
- Safe Sea SPF 50
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVOBENZONE | 30 mg/mL |
| HOMOSALATE | 100 mg/mL |
| OCTISALATE | 50 mg/mL |
| OCTOCRYLENE | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65435-0100-1 | Safe Sea SPF 50 | 118 mL in 1 BOTTLE | LOTION | 118 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65435-0100 | SAFE SEA SPF 50 (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) LOTION [NIDARIA TECHNOLOGY LTD] | 7 | Current NDC, Legacy NDC, 1 package rows | 20241123_53df3126-1136-490a-b339-5876ce89499e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65435-0100-1 | 65435010001 | 118 mL in 1 BOTTLE (65435-0100-1) | 118 ml | 2021-04-30 | 0000-00-00 | No | No | Current |
| 65435-0100-2 | 65435010002 | 100 mL in 1 TUBE (65435-0100-2) | 100 ml | 2021-11-05 | 0000-00-00 | No | No | Current |