DRY OIL SPF 15 (AVOBENZONE 1.5% HOMOSALATE 5% OCTOCRYLENE 3.5%) SPRAY [TOP CARE]

DRY OIL SPF 15 (AVOBENZONE 1.5% HOMOSALATE 5% OCTOCRYLENE 3.5%) SPRAY [TOP CARE]
PDF | XML

NDC 36800-731-05
Set ID 5df0cc44-ce0b-43af-81fc-6f70b7479c19
Category HUMAN OTC DRUG LABEL
Packager Top Care
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients                               Purpose
    Avobenzone 1.5%..............................Sunscreen
    Homosalate 5%.................................Sunscreen
    Octocrylene 3.5%..............................Sunscreen

  • INDICATIONS & USAGE

    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 sun

  • 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

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    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.

  • OTHER SAFETY INFORMATION

    Other information

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

  • INACTIVE INGREDIENT

    Inactive ingredients
    Acrylates/Dimethicone
    Copolymer, Acrylates/
    Octylacrylamide
    Copolymer, Alcohol
    Denat., Argania Spinosa
    Kernel Oil, Ascorbyl
    Palmitate, Cocos
    Nucifera (Coconut) Oil,
    Cyclopentasiloxane,
    Dimethicone, Fragrance,
    PPG-5-Ceteth-20,
    Passiflora Edulis Seed
    Oil, Polyester-8,
    Tocopheryl Acetate,
    Trisiloxane.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DRY OIL SPF 15 
    avobenzone 1.5% homosalate 5% octocrylene 3.5% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-731
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone1.5 g  in 100 g
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate5 g  in 100 g
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene3.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    PPG-5-Ceteth-20 (UNII: 4AAN25P8P4)  
    Passiflora Edulis Seed Oil (UNII: F3VOA31UHQ)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Trisiloxane (UNII: 9G1ZW13R0G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-731-05170 g in 1 CAN; Type 0: Not a Combination Product02/29/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/29/2016
    Labeler - Top Care (006935977)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(36800-731) , label(36800-731)

Related Drugs