Label: BALANCED SATIN FINISH FOUNDATION SPF 15- titanium dioxide, ethylhexyl methoxycinnamate lotion

  • Category: HUMAN OTC DRUG LABEL

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 7, 2017

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  • active ingredients

    titanium dioxide 10%

    ethylhexyl methoxycinnamate 2.5%

  • purpose

    sunscreen

  • use:

    •helps prevent sunburn

    •if used as directed with other sun protection measures (see directions),it 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

    when using this product keep out of eyes

    remove with water and mild cleanser

    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 centre right away

  • directions:

    •apply liberally 15 minutes before sun exposure

    •reapply after 40 minutes of swimming or sweating

    •reapply immediately after towel drying

    •reapply 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 value of 15 or higher and other sun protection measures including:

    •limit time in the sun, especially from 10 am to 2 pm

    •wear long-sleeved shirts, pants, hats, and sunglasses

    •children under 6 months of age: ask a doctor

  • inactive ingredients

    water, cyclopentasiloxane, butylene glycol, trimethylsiloxysilicate, PEG-10 dimethicone, silica, methicone, polymethyl methacrylate, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, lauryl PEG/PPG-18/18 methicone, sorbitan sesquioleate, disteardimonium hectorite, propylene carbonate, tribehenin, xanthan gum, dimethicone, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, sodium hyaluronate, magnesium stearate, sodium chloride, phenoxyethanol, ethylhexylglycerin, methylisothiazolinone, parfum, CI 77489, CI 77491, CI77492, CI 77499.

  • other information:

    protect this product from excessive heat and direct sun

  • questions:

    call toll free 1-877-438-1120

  • SPL UNCLASSIFIED SECTION

    Dist. by/Par: Modern Basic, Burnaby, BC/

    Garden Grove, CA. 

    Formulated for professional application.

    this carton is made from recycled paper 

    cruelty free - this product is not tested on animals

    Made in Canada

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    BALANCED SATIN FINISH FOUNDATION SPF 15 
    titanium dioxide, ethylhexyl methoxycinnamate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71305-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71305-100-101 in 1 BOX03/01/2017
    140 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2017
    Labeler - Modern Basic Distributors Ltd (208909999)