![JACKET SPF 50 (ZINC OXIDE, OCTINOXATE, OCTISALATE, OCTISALATE) CREAM [BALSHI MD DERMACEUTICALS]](https://medic.hrt.org//dailymed/images/b82b8a46-8009-416e-8718-296a23106914/Label2.jpg)
- 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.
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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:
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INGREDIENTS AND APPEARANCE
JACKET SPF 50
zinc oxide, octinoxate, octisalate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71070-768 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 75 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ARBUTIN (UNII: C5INA23HXF) ASCORBIC ACID (UNII: PQ6CK8PD0R) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL OLIVATE (UNII: 58B69Q84JO) CUCUMBER (UNII: YY7C30VXJT) CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) POMEGRANATE (UNII: 56687D1Z4D) SORBITAN OLIVATE (UNII: MDL271E3GR) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CORN (UNII: 0N8672707O) PROPANEDIOL (UNII: 5965N8W85T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71070-768-04 1 in 1 CARTON 11/18/2016 1 113 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/18/2016 Labeler - Balshi MD Dermaceuticals (010011434)
