ULTIMATE SHEER SPF 55 BODY (AVOBENZONE 3.00% HOMOSALATE 15.00% OCTISALATE 5.00% OCTOCRYLENE 2.75% OXYBENZONE 6.00%) SPRAY [TOPCO]

ULTIMATE SHEER SPF 55 BODY (AVOBENZONE 3.00% HOMOSALATE 15.00% OCTISALATE 5.00% OCTOCRYLENE 2.75% OXYBENZONE 6.00%) SPRAY [TOPCO]
PDF | XML

NDC 36800-722-04
Set ID 5a9c2f6d-1be4-47a8-9825-58f8a6b1ec0b
Category HUMAN OTC DRUG LABEL
Packager TopCo
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Avobenzone 3.00%, Homosalate 15.00%,
    Octisalate 5.00%, Octocrylene 2.75%,
    Oxybenzone 6.00%.

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Uses • helps prevent sunburn

  • WARNINGS

    Warnings
    For external use only
    Flammable: Do not use near heat, flame, or while smoking.
    Do not use on damaged or broken skin
    When using this product • Keep out of eyes. Rinse eyes with water
    to remove. • Keep away from face to avoid breathing it • Do not
    puncture or incinerate. Contents under pressure. Do not store at
    temperatures above 120ºF.
    Stop use and ask a doctor if rash occurs

  • Keep out of reach of children.

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

  • Directions


    • spray liberally and spread evenly by hand 15 minutes before sun exposure
    • reapply: • after 80 minutes of swimming or sweating
    • immediately after towel drying • at least every 2 hours
    • hold container 4 to 6 inches from the skin to apply • do not spray directly
    into face. Spray on hands then apply to face. • do not apply in windy
    conditions • use in a well-ventilated area
    Sun Protection Measures. Spending time in the sun increases your risk of
    skin cancer and early skin aging. To decrease this risk, regularly use a
    sunscreen with a broad spectrum SPF of 15 or higher and other sun
    protection measures including: • limit time in the sun, especially from
    10 a.m. – 2 p.m. • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients

    Acrylates Dimethicone Copolymer,
    Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Ascorbyl Palmitate,
    Cyclopentasiloxane, Dimethicone, Fragrance,
    Polyester-8, PPG-5-Ceteth-20, Retinyl Palmitate,
    Tocopheryl Acetate, Trisiloxane.

  • OTHER SAFETY INFORMATION

    Other information • protect this product from excessive heat and direct sun • may stain fabrics

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ULTIMATE SHEER SPF 55 BODY 
    avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 2.75% oxybenzone 6.00% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-722
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate15 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 g
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene2.75 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    PPG-5-Ceteth-20 (UNII: 4AAN25P8P4)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Trisiloxane (UNII: 9G1ZW13R0G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-722-04141 g in 1 CAN; Type 0: Not a Combination Product12/13/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/13/2012
    Labeler - TopCo (006935977)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(36800-722) , label(36800-722)

Related Drugs