Label: STUDIO BLEND COVER FOUNDATION SPF15- titanium dioxide, ethylhexyl methoxycinnamate 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 7, 2017

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  • ​Active Ingredients

    TITANIUM DIOXIDE 6.7%

    ETHYLHEXYL METHOXYCINNAMATE 2%

  • 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 Center right away.

  • Directions:

    • Apply liberally 15 minutes before sun exposure
    • Reapply at least every 2 hours.
    • Use a 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. Decrease this risk by regular use of sunscreen with a        Broad Spectrum SPF value of 18 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 am -2pm
    • Wear long-sleeved shirts, pants, hats, and sunglasses
    • Children under 6 months of age, ask a health care professional such as a Doctor.

  • Inactive Ingredients:

    aqua, isododecane, cyclopentasiloxane, butylene glycol, propylene glycol, glycerin, dicaprylyl carbonate, disteardimonium hectorite, propylene carbonate, cetyl peg/ppg- 10/1 dimethicone, peg-10 dimethicone, polyglyceryl-4 isostearate, silica, methicone, dimethicone, dimethicone/vinyl dimethicone crosspolymer, 1,2-hexanediol, hydroxyacetophenone, disodium edta, sodium chloride, magnesium sulfate, magnesium stearate, CI 77491, CI 77492, CI 77499

  • Other information:

    Store this product in a cool place away from heat or direct sunlight

  • 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.

    perfect your complexion with this full coverage formulation that is long wearing and blends easily to even out skin tone and has a matte finish
    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
    STUDIO BLEND COVER FOUNDATION SPF15 
    titanium dioxide, ethylhexyl methoxycinnamate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71305-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.7 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    4-HYDROXY ACETOPHENONE (UNII: G1L3HT4CMH)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71305-200-111 in 1 BOX03/01/2017
    130 mL in 1 TUBE; 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)
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