Islander Spf6 (Octinoxate, Octisalate, Avobenzone, Octocrylene) Lotion [Island Company Lifestyle Products, Llc] -

ISLANDER SPF6 (OCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [ISLAND COMPANY LIFESTYLE PRODUCTS, LLC]
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NDC	10755-006-02, 10755-006-08
Set ID	d62214ab-2e38-49bf-949c-00ec369f368e
Category	HUMAN OTC DRUG LABEL
Packager	Island Company Lifestyle Products, LLC
Generic Name
Product Class
Product Number
Application Number	PART352

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Labeler - Island Company Lifestyle Products, LLC (969086292)

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

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