Label: AVOBENZONE, HOMOSALATE, OCTISALATE spray

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 11, 2024

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  • Active Ingredients

    Avobenzone 3%

    Homosalate 12%

    Octisalate 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

  • Flammable

    Keep away from fire or flame. 

    • After application, wait until product dries before approaching a source of heat or flame, or before smoking
  • Do not use

    • on damaged or broken skin
  • When using this product

    • keep out of eyes. Rinse with water to remove
    • contents under pressure.  Do not puncture or incinerate.  Do not store at temperature above 120°F
  • Stop use and ask a doctor if 

    • rash occurs
  • Keep out of reach of children.

    If swallowed, seek immediate medical attention or call a poison control center.

  • Directions

    ■ spray liberally and spread evenly by hand 15 minutes before sun exposure
    ■ apply to all skin exposed to the sun
    ■ 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
    ■ 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 value 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
    ■ children under 6 months of age: Ask a doctor

  • Other information

    • protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    alcohol denat., diethylhexyl 2,6-naphthalate, diisopropyl adipate, acrylates/octylacrylamide copolymer, butyloctyl salicylate, neopentyl glycol diheptanoate, fragrance, tocopheryl acetate

  • Claims

    May stain or damage some fabrics or surfaces

    OCTINOXATE FREE, OXYBENZONE FREE

    *This product is not manufactured or distributed by Sun Bum LLC, distributor of Sun Bum  Premium Moisturizing Sunscreen Spray Broad Spectrum SPF 50.

  • Adverse Reaction

    DISTRIBUTED BY OLD EAST MAIN CO.

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

    100% Satisfaction Guaranteed!

    (888) 309-9030

    DSP-TN-21091

    DSP-MO-20087

  • Principal display panel

    STUDIO SELECTION ®

    SUN

    SUNSCREEN SPRAY

    BROAD SPECTRUM SPF 50

    Compare to Sun Bum ® Sunscreen Spray Broad Spectrum SPF 50*

    SPF 50

    Dermatologist-Tested

    Hypoallergenic

    Water-Resistant (80 minutes)

    Banana Scent

    NET WT 5.5 OZ (156 g)

    image description

  • INGREDIENTS AND APPEARANCE
    AVOBENZONE, HOMOSALATE, OCTISALATE 
    avobenzone, homosalate, octisalate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75712-949
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE120 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (40000 MW) (UNII: 7LL6SY9YFV)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75712-949-14156 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/25/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/25/2023
    Labeler - Old East Main Co. (006946172)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(75712-949)
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