JACKET ULTIMATE PERFORMANCE SUNSCREEN SPF 30- avobenzone, octisalate, octocrylene liquid

Jacket Ultimate Performance Sunscreen SPF 30 by

Drug Labeling and Warnings

Jacket Ultimate Performance Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by BALSHI MD DERMACEUTICALS, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone (3.00%)
Octisalate (5.00%)
Octocrylene (5.00%)

Purpose

Sunscreen

Uses:

• Helps prevent sunburn.
• higher SPF gives more sunburn protection
• Retains SPF after 80 minutes of swimming or sweating
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin agingcaused 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.

• Do not puncture or incinerate. Contents under pressure. Do not store it at temperatures above 120°F.

Stop use and ask a doctor if

• rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

ask a health professional before use.

Directions.

• Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months of age: ask a doctor.
• Reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• do not spray directly on face. Spray into hands and apply to face.
• Use in well-ventilated areas.
• Sun Protection Measures.Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 a.m.-2p.m.
• Wear long-sleeved shirts, pants,hats,and sunglasses.

Other Information

• Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Alcohol, Aloe Barbadensis Leaf Extract, Alpha-Arbutin, Ascorbyl Palmitate, Butyloctyl Salicylate, Camellia Sinensis Leaf Extract, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Cymbopogon Schoenanthus Oil, Helianthus Annuus (Sunflower) Seed Oil, Linum Usitatissimum (Linseed) Seed Oil, Methyl Dihydroabietate, Nelumbo Nucifera Flower Extract, Salvia Officinalis (Sage) Leaf Extract, Tocopheryl Acetate.

Questions?

www.jacketsunscreen.com

Package Labeling:

INGREDIENTS AND APPEARANCE

JACKET ULTIMATE PERFORMANCE SUNSCREEN SPF 30 
avobenzone, octisalate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71070-599
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - 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
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-ARBUTIN (UNII: 72VUP07IT5)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
COCONUT OIL (UNII: Q9L0O73W7L)
CUCUMBER (UNII: YY7C30VXJT)
CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LINSEED OIL (UNII: 84XB4DV00W)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
SAGE (UNII: 065C5D077J)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71070-599-00	177 mL in 1 CAN; Type 0: Not a Combination Product	04/08/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/08/2025

Labeler - BALSHI MD DERMACEUTICALS (010011434)

Registrant - Pure Source, LLC (080354456)