Label: FLORMAR PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 119 COCOA- octinoxate cream

  • 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 October 18, 2019

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  • flormar PERFECT COVERAGE FOUNDATION CREAM SUNSCREEN BROAD SPECTRUM SPF 15 119 Cocoa


  • Active ingredient

    Octinoxate 1%

    Purpose

    Sunscreen

  • 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

    For external use only

    Do not use

    on damaged or brokenskin

    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.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Shake well before use.
    • Apply liberally 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • 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.
    • Children under 6 months of age: Ask a doctor.
  • Other information

    • Protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    water, cyclopentasiloxane, isonnonyl isononanoate, diethylhexyl malate, butylene glycol, sorbitan olivate, HDI/trimethylol hexyllactone crosspolymer, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, magnesium aluminum silicate, glycerin, sweet almond (Prunus amygdalus dulcis) oil, polyglyceryl-4 isostearate, hydrogenated olive (Olea europaea) oil, phenoxyethanol, aluminum hydroxide, polyglyceryl-3 polydimethyl siloxyethyl dimethicone, triethoxycaprylylsilane, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, olive (Olea europaea) fruit oil, stearic acid, bisabolol, fragrance, methylparaben, propylene glycol, olive (Olea europaea) oil unsaponifiables, PEG-8, silica, tocopherol, glyceryl acrylate/acrylic acid copolymer, ascorbyl palmitate, PVM/MA copolymer, ascorbic acid, citric acid, propylparaben, linalool, butylphenyl methylpropional, alpha-isomethyl ionone, citronellol, benzyl salicylate, citronellol, benzyl salicylate, geraniol, coumarin, titanium dioxide, iron oxides.

  • flormar PERFECT COVERAGE FOUNDATION CREAM SUNSCREEN BROAD SPECTRUM SPF 15 119 Cocoa 30ml (61722-091-00)

    Perfect Coverage 1Perfect Coverage 2Perfect Coverage 3

  • INGREDIENTS AND APPEARANCE
    FLORMAR PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 119 COCOA 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61722-091
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    DIETHYLHEXYL MALEATE (UNII: C2F7JHI12L)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    GERANIOL (UNII: L837108USY)  
    COUMARIN (UNII: A4VZ22K1WT)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61722-091-001 in 1 BOX07/21/2014
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/21/2014
    Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)