Label: FIRST AID ONLY SUNX30 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion

  • 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 February 18, 2021

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  • Active ingredients

    Avobenzone 3%

    Homosalate 7.5%

    Octisalate 5%

    Octocylene 5%

  • Purpose

    Sunscreen

    Sunscreen

    Sunscreen

    Sunscreen

  • Warnings

    For external use only

    Do not use

    on damaged or broken skin

    When using this product

    keep out of the eyes. Rinse with water to remove

    Stop use and ask a doctor

    if rash occurs

    Keep out of the reach of children.

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

  • 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.
  • Directions

    • apply liberally 15 minutes before sun exposure
    • 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 10:00 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses.

    Children under 6 months: Ask a doctor

  • Other information

    • Protect this product from excessive heat or direct sun.
  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, C12-15 alkyl benzoate, carbomer, disodium EDTA, ethylhexylglycerin, hydroxypropyl methylcellulose, phenoxyethanol, polyethylene, polysorbate 20, propylene glycol, sodium hydroxide, sorbitan, oleate, theobroma cacao (cocoa) seed butter, tocopherol acetate, water

  • Questions

    1-800-835-2263

  • PRINCIPAL DISPLAY PANEL

    carton image carton image

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY SUNX30 SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0801(NDC:65753-106)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
    THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
    PROPYLENE GLYCOL PROPYL ETHER (UNII: 92KA3PYX0S)  
    MEDIUM DENSITY POLYETHYLENE (UNII: 3W404QE89S)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0801-014 in 1 CARTON02/22/2021
    17 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/22/2021
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-0801) , repack(0924-0801)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-0801) , repack(0924-0801)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation117825595relabel(0924-0801) , repack(0924-0801)
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