![JACKET SPF-50 BROAD SPECTRUM SUNSCREEN (ZINC OXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [BALSHI MD DERMACEUTICALS]](https://medic.hrt.org//dailymed/images/fcc45edd-098c-4f27-9712-0db36cfa0fdc/Label.jpg)
| NDC | 71070-868-04 |
| Set ID | fcc45edd-098c-4f27-9712-0db36cfa0fdc |
| Category | HUMAN OTC DRUG LABEL |
| Packager | BALSHI MD DERMACEUTICALS |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Drug Facts
- Active Ingredients
- Uses
- Warnings
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Directions
• Apply liberally 15 minutes before sun exposure • Reapply: *At least every 2 hours *Immediately after swimming, sweating or towel drying
Sun Protection Measures: 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:
*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, Allantoin, 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 Olivate, Cetyl Alcohol, Cucumis Sativus (Cucumber) Fruit Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Cymbopogon Schoenanthus (Lemongrass) Oil, Dimethicone, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Oil, Magnesium Aluminum Silicate, Phenoxyethanol, Polysorbate 20, Punica Granatum (Pomegranate) Extract, Sorbitan Olivate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Zema (Corn) Propanediol
- Other Information
- Package Labeling:
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INGREDIENTS AND APPEARANCE
JACKET SPF-50 BROAD SPECTRUM SUNSCREEN
zinc oxide, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71070-868 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 60 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ASCORBIC ACID (UNII: PQ6CK8PD0R) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETEARYL OLIVATE (UNII: 58B69Q84JO) CETYL ALCOHOL (UNII: 936JST6JCN) CUCUMBER (UNII: YY7C30VXJT) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 4 (UNII: CZ227117JE) CYMBOPOGON CITRATUS LEAF (UNII: 06JMS448M5) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LICORICE (UNII: 61ZBX54883) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) POMEGRANATE (UNII: 56687D1Z4D) SORBITAN OLIVATE (UNII: MDL271E3GR) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) CORN (UNII: 0N8672707O) PROPANEDIOL (UNII: 5965N8W85T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71070-868-04 120 mL in 1 TUBE; Type 0: Not a Combination Product 04/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/15/2019 Labeler - BALSHI MD DERMACEUTICALS (010011434)
