JACKET SPF 50
- Product NDC
- 71070-768
- 11-digit product format
- 710700768
- Labeler code
- 71070
- Product ID
- 71070-768_0974579b-6f81-6b47-e063-6294a90a0217
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ZINC OXIDE, OCTINOXATE, OCTISALATE, OCTISALATE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Balshi MD Dermaceuticals
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-11-18
- Substance
- OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE
- Active strength
- 75; 50; 50; 75 mg/g; mg/g; mg/g; mg/g
- Pharmacologic classes
- Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- JACKET SPF 50
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OCTINOXATE | 75 mg/g |
| OCTISALATE | 50 mg/g |
| OXYBENZONE | 50 mg/g |
| ZINC OXIDE | 75 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4Y5P7MUD51, 4X49Y0596W, 95OOS7VE0Y, SOI2LOH54Z |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71070-768-04 | JACKET SPF 50 | 1 in 1 CARTON | CREAM | 1 | | 3 |
| 71070-768-04 | JACKET SPF 50 | 113 g in 1 BOTTLE | CREAM | 113 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71070-768 | JACKET SPF 50 (ZINC OXIDE, OCTINOXATE, OCTISALATE, OCTISALATE) CREAM [BALSHI MD DERMACEUTICALS] | 3 | Current NDC, Legacy NDC, 2 package rows | 20231106_b82b8a46-8009-416e-8718-296a23106914.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71070-768-04 | 71070076804 | 1 BOTTLE in 1 CARTON (71070-768-04) / 113 g in 1 BOTTLE | 1 bottle | 2016-11-18 | 0000-00-00 | No | No | Current |