KEY WEST TAN SPF15 (OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) LOTION [QS KEY WEST ALOE, LLC]

KEY WEST TAN SPF15 (OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) LOTION [QS KEY WEST ALOE, LLC]
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NDC 65008-004-08
Set ID ffc74655-dae4-43e8-adee-f88a71eebb9d
Category HUMAN OTC DRUG LABEL
Packager QS Key West Aloe, LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • ​ ​Active Ingredients

    Octinoxate 5.0% (w/w)

    Octisalate  3.0% (w/w)

    Oxybenzone 2.0% (w/w)

    Avobenzone 2.0% (w/w)

    Octocrylene 1.5% (w/w)

  • ​Purpose

    Sunscreen

  • ​Uses

    - Helps prevent sunburn

    - If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • ​Warnings

    ​For external use only

    Do not use on damaged or broken skin

    ​When using this product

    - Keep out of eyes.  Rinse with water to remove.

  • STOP USE

    ​Stop use and ask a doctor if

    - Rash or irritation develops and lasts

  • KEEP OUT OF REACH OF CHILDREN

    ​Keep out of reach of children.

    - If product is swallowed, get medical help or contact a Poison Control Center right away.

  • ​Directions

    - Apply liberally 15 minutes before sun exposure

    - Reapply

      - After 80 minutes of swimming or sweating

      - Immediately after towel drying

      - At least every 2 hrs

    - ​Sun Protection Measures​.  Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease the risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other skin protection measures including:

      - limit time in the sun, especially from 10 a.m. - 2 p.m.

      - wear long-sleeve shirts, pants, hats, and sunglasses

  • ASK DOCTOR/PHARMACIST

    - ​Children under 6 months:​ Ask a doctor

  • ​Inactive Ingredients:

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

  • ​Other Information

    - Protect this product from excessive heat and direct sun.

  • ​Questions or Comments?

    1-800-445-2563

  • PRINCIPAL DISPLAY PANEL

    8oz Tube

  • INGREDIENTS AND APPEARANCE
    KEY WEST TAN SPF15 
    octinoxate, octisalate, oxybenzone, avobenzone, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65008-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65008-004-08227 g in 1 TUBE; Type 0: Not a Combination Product02/26/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/07/2004
    Labeler - QS Key West Aloe, LLC (969600555)

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