JACKET SPF 50- zinc oxide, octinoxate, octisalate, octisalate cream

JACKET SPF 50 by

Drug Labeling and Warnings

JACKET SPF 50 by is a Otc medication manufactured, distributed, or labeled by Balshi MD Dermaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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 
• 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, 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:

INGREDIENTS AND APPEARANCE

JACKET SPF 50 
zinc oxide, octinoxate, octisalate, octisalate cream

Product 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)