Standard Procedure SPF 50 Sunscreen
- Product NDC
- 84425-101
- 11-digit product format
- 844250101
- Labeler code
- 84425
- Product ID
- 84425-101_4862fbef-e8ad-cc4b-e063-6394a90a35f2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Homosalate, Octocrylene, Octisalate, Avobenzone
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Standard Procedure Inc
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-07-15
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
- Active strength
- 30; 100; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Standard Procedure SPF 50 Sunscreen
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVOBENZONE | 30 mg/mL |
| HOMOSALATE | 100 mg/mL |
| OCTISALATE | 50 mg/mL |
| OCTOCRYLENE | 80 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 |
|---|
| 84425-101-01 | Standard Procedure SPF 50 Sunscreen | 60 mL in 1 BOTTLE, PLASTIC | LOTION | 60 | | 2 |
| 84425-101-03 | Standard Procedure SPF 50 Sunscreen | 250 mL in 1 BOTTLE, PLASTIC | LOTION | 250 | | 2 |
| 84425-101-04 | Standard Procedure SPF 50 Sunscreen | 500 mL in 1 BOTTLE, PLASTIC | LOTION | 500 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 84425-101 | STANDARD PROCEDURE SPF 50 SUNSCREEN (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) LOTION [STANDARD PROCEDURE INC] | 1 | Current NDC, 3 package rows | 20240821_1d3f87de-90c0-75c0-e063-6394a90a2ef4.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84425-101-01 | 84425010101 | 60 mL in 1 BOTTLE, PLASTIC (84425-101-01) | 60 ml | 2024-07-15 | No | No | Current |
| 84425-101-03 | 84425010103 | 250 mL in 1 BOTTLE, PLASTIC (84425-101-03) | 250 ml | 2024-07-15 | No | No | Current |
| 84425-101-04 | 84425010104 | 500 mL in 1 BOTTLE, PLASTIC (84425-101-04) | 500 ml | 2024-07-15 | No | No | Current |