TOURIST SPF30- octinoxate, octisalate, oxybenzone, avobenzone, octocrylene lotion
Island Company Lifestyle Products, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

tourist spf30

Active Ingredients Purpose

Octinoxate 7.5% Sunscreen

Octisalate 5.0% Sunscreen

Oxybenzone 5.0% 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

Tourist SPF30 8oz Label

Tourist SPF30 2oz Label

FDA Label

TOURIST SPF30
octinoxate, octisalate, oxybenzone, avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10755-030
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 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)

#	Item Code	Package Description
Packaging
1	NDC:10755-030-08	236 g in 1 BOTTLE
2	NDC:10755-030-02	60.9 g in 1 PACKAGE

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(10755-030)