Label: TOURIST SPF30- octinoxate, octisalate, oxybenzone, avobenzone, octocrylene lotion

  • 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

If you are a consumer or patient please visit this version.

  • 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

  • PRINCIPAL DISPLAY PANEL

    Tourist SPF30 8oz Label

  • PRINCIPAL DISPLAY PANEL

    Tourist SPF30 2oz Label

  • PRINCIPAL DISPLAY PANEL

    FDA Label

  • INGREDIENTS AND APPEARANCE
    TOURIST SPF30 
    octinoxate, octisalate, oxybenzone, avobenzone, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10755-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10755-030-08236 g in 1 BOTTLE
    2NDC:10755-030-0260.9 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2009
    Labeler - Island Company Lifestyle Products, LLC (969086292)
    Establishment
    NameAddressID/FEIBusiness Operations
    A.I.G. Technologies, Inc.171837367manufacture(10755-030)