Indications and uses
Helps prevent sunburn If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.
JACKET SPF 50+ CREAM
- Manufacturer
- Balshi MD Dermaceuticals
- Effective date
- 2023-11-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:59:05
Label at a glance#
ProductJACKET SPF 50
Active ingredientZINC OXIDE, OCTINOXATE, OCTISALATE, OXYBENZONE
Label structure6 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure • Reapply: • At least every 2 hours • Immediately after swimming, sweating or towel drying Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: Sun Protection Measures: Limit...
Label contents#
Full prescribing information#
Active Ingredients
Zinc Oxide 7.50%
Octinoxate 7.50%
Octisalate 5.00%
Oxybenzone 5.00%
Purpose
Sunscreen
Uses
Helps prevent sunburn
- If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
- For external use only.
Do not use
on damaged or broken skin
When using this product
keep out of eyes. Rinse with water to remove
Stop use and consult physician if
irritation or rash develops
Keep out if reach of children.
If product is swallowed, get medical attention or contact poison control center immediately.
Directions
- Apply liberally 15 minutes before sun exposure • Reapply: • At least every 2 hours • Immediately after swimming, sweating or towel drying
- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: Sun Protection Measures:
- Limit time in the sun, especially between 10am -2pm
- Wear long sleeve shirts, pants, hats and sunglasses
- For children under 6 months, consult a physician.
Other Ingredients
Acrylates Copolymer, Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), A-Arbutin, Ascorbic Acid (Vitamin C), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Ceteareth 20, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Alcohol Cucumis Sativus (Cucumber) Fruit Extract, Cymbopogon Schoenanthus (Lemongrass) Oil, Dimethicone, Ethylhexylgycerin, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Oil, Phenoxyethanol, Polysorbate 20, Punica Granatum (Pomegranate) Extract, Sorbitan Olivate, Stearyl Alcohol, Tocopheyl Acetate (Vitamin E), Zema (Corn), Propanediol
Package Labeling:
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| 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#
Products#
Every source-derived product name is available through these pages.
- JACKET SPF 50
- ZINC OXIDE, OCTINOXATE, OCTISALATE, OCTISALATE
- ALOE VERA LEAF
- WATER
- ARBUTIN
- ASCORBIC ACID
- GREEN TEA LEAF
- MEDIUM-CHAIN TRIGLYCERIDES
- POLYOXYL 20 CETOSTEARYL ETHER
- CETOSTEARYL ALCOHOL
- CETEARYL OLIVATE
- CUCUMBER
- CYMBOPOGON SCHOENANTHUS OIL
- DIMETHICONE
- ETHYLHEXYLGLYCERIN
- ETHYLHEXYL PALMITATE
- GLYCERIN
- GLYCERYL MONOSTEARATE
- GLYCYRRHIZA GLABRA
- HELIANTHUS ANNUUS FLOWERING TOP
- PHENOXYETHANOL
- POLYSORBATE 20
- POMEGRANATE
- SORBITAN OLIVATE
- STEARYL ALCOHOL
- .ALPHA.-TOCOPHEROL
- CORN
- PROPANEDIOL
- ZINC OXIDE
- ZINC CATION
- OCTINOXATE
- OCTISALATE
- OXYBENZONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71070-768 | 71070-768-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| JACKET SPF 50 | ZINC OXIDE, OCTINOXATE, OCTISALATE, OCTISALATE | Balshi MD Dermaceuticals | b82b8a46-8009-416e-8718-296a23106914 | 2023-11-05 | Warnings | 71070-768-04 71070-768 71070076804 0974579b-6f81-6b47-e063-6294a90a0217 b82b8a46-8009-416e-8718-296a23106914 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.