Label: EQUATE BEAUTY ROAD SPECTRUM SPF30- 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 April 19, 2016

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

  • ACTIVE INGREDIENT

    Active ingredients

    Avobenzone 2.0%

    Homosalate 4.0%

    Octisalate 4.0%

    Octocrylene 2.0%

  • PURPOSE

    Purpose

    Sunscreen

    Sunscreen

    Sunscreen

    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 and early aging caused by the sun
  • WARNINGS

    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.

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use water resistant sunscreen if swimming or sweating
    • 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 sking 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

  • STORAGE AND HANDLING

    Other Information - protect the product in this container from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Inactive Ingredients water, dimethicone, trisiloxane, isononyl isononanoate, glycerin,

    cetyl alcohol, steareth-21, nylon-12, silica, stearyl alcohol, glyceryl stearate, PEG-100 stearate,

    phenoxyethanol, ethylhexylglycerin, dimethicone crosspolymer, sodium styrene/acrylates/divinylbenzene

    copolymer, ammonium nonoxynol-4 sulfate, fragrance, propylene glycol, myrtus communis extract,

    xantan gum, retinyl palmitate, polysorbate 20, acrylates/C10-30 alkyl acrylate crosspolymer,

    disodium EDTA, ascorbic acid, sodium hydroxide, BHT, hyaluronic acid

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    EQUATE BEAUTY  ROAD SPECTRUM SPF30
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE.02 g  in 29 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE.04 g  in 29 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE.04 g  in 29 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE.02 g  in 29 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARETH-21 (UNII: 53J3F32P58)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    STYRENE (UNII: 44LJ2U959V)  
    SODIUM (UNII: 9NEZ333N27)  
    DIVINYLBENZENE (UNII: IZ715T4SBU)  
    AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MYRTUS COMMUNIS LEAF (UNII: U20N87188F)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALLYL ACRYLATE (UNII: 705GA5O3US)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TRIS-BHT MESITYLENE (UNII: 51DM34B894)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-300-161 in 1 CARTON04/15/2016
    129 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/15/2016
    Labeler - Wal-Mart Stores, Inc (051957769)