Label: TOURIST SPF30- octinoxate, octisalate, oxybenzone, avobenzone, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 10755-030-02, 10755-030-08 - Packager: Island Company Lifestyle Products, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 14, 2014
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- Active Ingredients Purpose
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INGREDIENTS AND APPEARANCE
TOURIST SPF30
octinoxate, octisalate, oxybenzone, avobenzone, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10755-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 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:10755-030-08 236 g in 1 BOTTLE 2 NDC:10755-030-02 60.9 g in 1 PACKAGE 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(10755-030)