ISLANDER SPF6- octinoxate, octisalate, avobenzone, octocrylene lotion

islander spf6 by

Drug Labeling and Warnings

islander spf6 by is a Otc medication manufactured, distributed, or labeled by Island Company Lifestyle Products, LLC, A.I.G. Technologies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients     Purpose

Octinoxate 5.0%         Sunscreen

Octisalate 3.0%          Sunscreen

Oxybenzone 2.0%       Sunscreen

Avobenzone 2.0%       Sunscreen

Octocrylene 1.5%       Sunscreen

Uses

• Helps prevent sunburn
• Higher SPF gives more sunburn protection

Warnings

• For external use only
• Keep out of reach of children

When using this product

• Keep out of eyes.  Rinse with water to remove

Stop use and ask doctor if

• Rash or irritation develops and lasts

Directions

• Apply liberally 20 minutes before sun exposure and as needed
• For children under 6 months of age: Ask a doctor

Other Information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun

Inactive Ingredients

Water, Adipic Acid/Diethylene Gylcol Glycerin Crosspolymer, Polycrylene, Isopropyl Myristate, Fragrance, Propylene Glycol, Hydrogenated Polyisobutene, Polyethylene, Aloe Barbadensis Leaf Extract, Allantoin, Sodium Ascorbic Phosphate, Tocopheryl Acetate, Retinyl Palmitate, Cetyl Alcohol, Triethanolimine, C12-15 Alkyl Benzoate, Sorbitan Stearate, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Carbomer, Carpylyl Glycol, Disodium EDTA, Methylisothiazolinone

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ISLANDER SPF6 
octinoxate, octisalate, avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10755-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	20 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	15 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID (UNII: 76A0JE0FKJ)
DIETHYLENE GLYCOL (UNII: 61BR964293)
GLYCERIN (UNII: PDC6A3C0OX)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
TROLAMINE (UNII: 9O3K93S3TK)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10755-006-08	236 g in 1 BOTTLE
2	NDC: 10755-006-02	59 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2009

Labeler - Island Company Lifestyle Products, LLC (969086292)

Establishment
Name	Address	ID/FEI	Business Operations
A.I.G. Technologies, Inc.		171837367	manufacture(10755-006)