JACKET SPF 50- zinc oxide, octinoxate, octisalate, octisalate cream 
Balshi MD Dermaceuticals

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JACKET SPF 50+ CREAM

Drug Facts

Active Ingredients

Zinc Oxide 7.50%

Octinoxate 7.50%

Octisalate 5.00%

Oxybenzone 5.00%

Purpose

Sunscreen

Uses 

Helps prevent sunburn

Warnings

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

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:

Label2

JACKET SPF 50 
zinc oxide, octinoxate, octisalate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71070-768
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION75 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71070-768-041 in 1 CARTON11/18/2016
1113 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/18/2016
Labeler - Balshi MD Dermaceuticals (010011434)

Revised: 11/2023
Document Id: 0974579b-6f81-6b47-e063-6294a90a0217
Set id: b82b8a46-8009-416e-8718-296a23106914
Version: 3
Effective Time: 20231105
 
Balshi MD Dermaceuticals