Label: OLEANDER NO-AD BROAD SPECTRUM SPF- avobenzone, homosalate, octisalate, octocrylene spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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  • Active Ingredients

    Avobenzone 3%

    Homosalate 7.5%

    Octisalate 5%

    Octocrylene 5%

  • 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.
    • Keep away from face to avoid breathing it.

    Stop use and ask doctor

    if rash or irritation develops and lasts.

    Keep out of reach of children.

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

    Flammable

    Do not use near heat, flame or while smoking.

    Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120ºF. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

  • Directions

    • Shake well. Spray liberally and spread evenly by hand 15 minutes before sun exposure
    • 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 and avoid inhalation.
    • Children under 5 months of age: ask a doctor
    • Reapply:
    • after 80 minutes of swimming or sweating
    • Immediately after towel drying
    • at least every 2 hours
    • 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-sleeved shirts, pants, hats, and sunglasses
  • Other Information

    • Protect this product from excessive heat and direct sun
    • Store between 20° and 25°C (68º to 77°F)
    • May stain some fabrics/materials or surfaces
  • Inactive Ingredients

    Fragrance, Polysilicone-15, SD Alcohol 40-B, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

  • NO-AD Sunscreen Broad Spectrum SPF 30 Continuous Spray

    Principle Display Label

  • INGREDIENTS AND APPEARANCE
    OLEANDER NO-AD  BROAD SPECTRUM SPF
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0282
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE63.68 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE42.45 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE42.45 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25.47 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    Coloryellow (Light Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0282-5255 g in 1 CAN; Type 0: Not a Combination Product10/26/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/26/2023
    Labeler - Prime Packaging, Inc. (805987059)
    Registrant - Prime Packaging, Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(13630-0282) , label(13630-0282) , analysis(13630-0282) , pack(13630-0282)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging, Inc.805987059label(13630-0282) , pack(13630-0282)
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