Label: HELP ME BROAD SPECTRUM SPF 30 SUNSCREEN RETINOL DAY TREATMENT LOTION- avobenzone liquid

  • 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 11, 2012

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  • ACTIVE INGREDIENT

    Avobenzone 2.0%

    Homosalate 10.0%

    Octisalate 5.0%

    Octocrylene 1.5%

    Oxybenzone 4.0%

  • PURPOSE

    Avobenzone: Sunscreen

    Homosalate: Sunscreen

    Octisalate: Sunscreen

    Octocrylene: Sunscreen

    Oxybenzone: Sunscreen

  • 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.

  • INDICATIONS & USAGE

    • 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. If sensitive to retinol, use once every 2-3 days build to a daily use as tolerated.

    When using this product keep out of eyes, rinse with water to remove.

    Stop use and ask a doctor if rash occurs.
  • DOSAGE & ADMINISTRATION

    • apply liberally 15 minutes before sun exposure on clean dry skin, avoiding the eye area
    • reapply at least every 2 hours when using as a sunscreen
    • 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 int he sun, especially from 10 a.m.-2 p.m.
                                   wear long sleeve shirts, pants, hats and sunglasses
                                   ask a doctor. this product should NOT be used on children of any age.
  • INACTIVE INGREDIENT

    water, c12-15 alkyl benzoate, butylene glycol, glycerin, potassium cetyl phosphate, methyl methacrylate/glycol dimethacrylate crosspolymer, arachidyl alcohol, dimethicone, glyceryl myristate, peg-100 stearate, sodium hyaluronate, retinol, picea abies wood extract, ethylhexylglycerin, tocopheryl acetate, dipotassium glycyrrhizate, arachidyl glucoside, bentonite, allyl methacrylates crosspolymer, acrylates/c10-30 alkyl acrylate crosspolymer, behenyl alcohol, sodium hydroxide, disodium edta, bht, erythorbic acid, polysorbate 20, chlorphenesin, titanium dioxide, phenoxyethanol.

  • PRINCIPAL DISPLAY PANEL

    HelpMe_outer

  • PRINCIPAL DISPLAY PANEL

    HelpMe_inner

  • INGREDIENTS AND APPEARANCE
    HELP ME  BROAD SPECTRUM SPF 30 SUNSCREEN RETINOL DAY TREATMENT LOTION
    avobenzone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-1000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.6 mL  in 30 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate3 mL  in 30 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate1.5 mL  in 30 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.45 mL  in 30 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone1.2 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    butylene glycol (UNII: 3XUS85K0RA)  
    glycerin (UNII: PDC6A3C0OX)  
    potassium cetyl phosphate (UNII: 03KCY6P7UT)  
    arachidyl alcohol (UNII: 1QR1QRA9BU)  
    dimethicone (UNII: 92RU3N3Y1O)  
    glyceryl myristate (UNII: 6992Y81827)  
    peg-100 stearate (UNII: YD01N1999R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    retinol (UNII: G2SH0XKK91)  
    PICEA ABIES FLOWER BUD (UNII: WQZ50FAU2B)  
    ethylhexylglycerin (UNII: 147D247K3P)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    arachidyl glucoside (UNII: 6JVW35JOOJ)  
    bentonite (UNII: A3N5ZCN45C)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    sodium hydroxide (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    erythorbic acid (UNII: 311332OII1)  
    polysorbate 20 (UNII: 7T1F30V5YH)  
    chlorphenesin (UNII: I670DAL4SZ)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50184-1000-130 mL in 1 BOX
    2NDC:50184-1000-230 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2012
    Labeler - Philosophy Inc. (948102256)
    Registrant - Philosophy Inc. (948102256)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bio Tech Research Labs948102256manufacture
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