FRE BROAD SPECTRUM (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [EMILIA PERSONAL CARE INC]

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  • FRE BROAD SPECTRUM (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [EMILIA PERSONAL CARE INC]

FRE BROAD SPECTRUM (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [EMILIA PERSONAL CARE INC]
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NDC 42421-600-20, 42421-600-60
Set ID aeb0b914-db57-4c32-adf1-b6d0b355b3ab
Category HUMAN OTC DRUG LABEL
Packager Emilia Personal Care Inc
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    Active ingredients

    Avobenzon 3.0%

    Homosalate, 8.0%

    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 early skin 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 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

  • INACTIVE INGREDIENT

    Inactive ingredients  water, glycerin, styrene/acrylates copolymer, glyceryl

    stearate, PEG-100 stearate, cetearyl alcohol, cetearyl glucoside, caprylyl methicone, dimethicone, trisiloxanane,

    argania spinosa kernel oil, ascorbyl glucoside,

    phenoxyethanol, ethylhexylglycerin, potassium cetyl

    phosphate, hydrogenated palm glyceride, diethylhexyl

    2,6-naphthalate, behenyl alcohol, argania spinosa leaf

    extract, maltodextrin, panthenol (pro-vitamin B5), butylene

    glycol, pentylene glycol, hydroxyphenol propamidobenzoic

    acid, polymethyl methacrylate, fragrance, disodium EDTA,

    xanthan gum, tocopheryl acetate (vitamin E), bisabolol,

    camosine, BHT, retinyl palmitate (vitamin A), chamomilla

    recutita (matricaria) flower extract, melissa officinalis leaf

    extract, aspalathus linearis (rooibos) leaf extract, tilia

    vulgaris (linden blossom) flower extract

  • PRINCIPAL DISPLAY PANEL

    image description

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FRE   BROAD SPECTRUM
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42421-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.8 g  in 60 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.8 g  in 60 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.4 g  in 60 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.2 g  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STYRENE (UNII: 44LJ2U959V)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ARGANIA SPINOSA LEAF (UNII: 51XV5WTF7E)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHAMOMILE (UNII: FGL3685T2X)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42421-600-6060 mL in 1 TUBE; Type 0: Not a Combination Product06/28/2016
    2NDC:42421-600-2020 mL in 1 TUBE; Type 0: Not a Combination Product08/13/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/28/2016
    Labeler - Emilia Personal Care Inc (965445112)
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