Label: SOLIMO SPORT SPF 50 BROAD SPECTRUM SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene aerosol, spray

  • NDC Code(s): 72288-209-38
  • Packager: Amazon.com Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 12, 2020

If you are a consumer or patient please visit this version.

  • Active ingredients

    Avobenzone 3.0%

    Homosalate 10.0%

    Octisalate 5.0%

    Octocrylene 4.0%

  • Purpose

    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 casued by the sun
  • Warnings

    For external use only

  • FLAMMABLE:

    • do not use near heat, flame or while smoking
    • avoid long term storage above 104ºF (40ºC)
  • DO NOT USE

    Do not use

    • on damaged or broken skin.
  • WHEN USING

    When using this product

    • keep out of eyes. Rinse 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.
  • ASK DOCTOR

    Stop use and ask a doctor if

    • rash occurs.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If 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

    Hold can 4-6 inches away from the skin to apply

    Do not spray directly into face. Spray into hands then apply to face

    Do not apply in windy conditions

    Use in a well-ventilated area

    reapply:

    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours

    children under 6 months of age: ask a doctor

    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
  • Other information

    • protect this product from excessive heat and direct sun
    • may stain or damage some fabrics, materials or surfaces
  • Inactive ingredients

    alcohol denat., butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol, tocopherol, fragrance, stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin

  • Questions or comments?

    Call toll free 1-877-485-0385

  • PRINCIPAL DISPLAY PANEL

    SOLIMO SPORT SPF 50 BROAD SPECTRUM SUNSCREEN SPRAY

    11 OZ. (312g)

    NDC 72288-209-38

    Label

  • INGREDIENTS AND APPEARANCE
    SOLIMO SPORT SPF 50 BROAD SPECTRUM SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-209
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    ALCOHOL (UNII: 3K9958V90M)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72288-209-38312 g in 1 CAN; Type 0: Not a Combination Product05/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/28/2020
    Labeler - Amazon.com Services LLC (128990418)