ISA KNOX 365 SUNSCREEN BROAD SPECTRUM SPF 50 PLUS- homosalate, octisalate, avobenzone, octocrylene cream

ISA KNOX 365 SUNSCREEN BROAD SPECTRUM SPF 50 Plus by

Drug Labeling and Warnings

ISA KNOX 365 SUNSCREEN BROAD SPECTRUM SPF 50 Plus by is a Otc medication manufactured, distributed, or labeled by LG Household and Healthcare, Inc., Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ISA KNOX 365 SUNSCREEN CREAM BROAD SPECTRUM SPF 50+

Active ingredients

Homosalate 10.0%

Octisalate 5.0 %

Avobenzone 3.0%

Octocrylene 2.6%

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 ask a doctor if rash occurs.

Keep out of reach of children.

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

Directions

• Apply liberally 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Children under 6 months: Ask a doctor
• Apply to all skin exposed to the sun

Other information

Protect this product from excessive heat and direct sun

Inactive ingredients

• Water, CapryM Methicone, Dipropylene Glycol, Dicaprylyl Carbonate, PEG/PPG-17/6 Copolymer, Methyl Glucose Sesquistearate, SD Alcohol 40-B, Butylene Glycol, Adenosine, Euterpe Oleracea Fruit Extract, Portulaca Oleracea Extract, Morus Alba Bark Extract, Camellia Sinensis Leaf Extract, Dipotassium Glycynbizate, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Panthend, Cetyl Alcohol, Caprylyl Glycol, Hydrogenated Palm Glycerides, Tocopheryl Acetate, PEG-10 Dimethicone, Polyacrylate-15, Polyacrylate-17, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Potassium Hydroxide, Disodium EDTA

ISA KNOX 365 SUNSCREEN CREAM BROAD SPECTRUM SPF 50+ 2oz/60ml (

53208-002-00)

INGREDIENTS AND APPEARANCE

ISA KNOX 365 SUNSCREEN BROAD SPECTRUM SPF 50 PLUS 
homosalate, octisalate, avobenzone, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53208-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	26 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ADENOSINE (UNII: K72T3FS567)
ACAI (UNII: 46AM2VJ0AW)
PURSLANE (UNII: M6S840WXG5)
MORUS ALBA BARK (UNII: 7O71A48NDP)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PANTHENOL (UNII: WV9CM0O67Z)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PALM KERNEL GLYCERIDES (UNII: W0N2263KJZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIPROPYLENE GLYCOL (UNII: E107L85C40)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53208-002-00	1 in 1 PACKAGE	12/19/2017
1		60 mL in 1 TUBE; 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	10/28/2014

Labeler - LG Household and Healthcare, Inc. (688276187)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(53208-002)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(53208-002)