Label: FLORMAR DELICIOUS LIPSTICK STYLO SUNSCREEN BROAD SPECTRUM SPF 15 DS03 DOLL PHOTOMONTAGE- titanium dioxide stick

  • 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

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient

    Titaniuim Dioxide 2%

    Purpose

    Sunscreen

  • Use

    • 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

    Do not use

    on damaged or broken skin

    Stop use and ask a doctor if

    rash occurs

  • Directions

    • Apply on the center of the lips and blend
    • 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
  • Other information

    Protect this product in this container from excessive heat and direct sun

  • Inactive ingredients

    DIISOSTEARYL MALATE, TRIDECYL TRIMELLIATATE, CASTOR (RICINUS COMMUNIS (CASTOR) SEED OIL, POLYETHYLENE, OCTYLDODECANOL,
    HYDROGENATED POLYDECENE, PHENYL TRIMETHICONE, MICROCRYSTALLINE WAX, SILICA, MICA, BIS-DIGLYCERYL POLYACYLADIPATE-2, TRIISOSTEARYL CITRATE, CANDELILLA (EUPHORBIA CERIFERA) WAX, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PENTAERTHRITYL TETRABEHENATE, POLYMETHYL METHACRYLATE, POLYBUTENE, SHEA (BUTYROSPERMUM PARKII) BUTTER, COCOA (THEOBROMA CACAO) SEED BUTTER, CAPRYLIC/CAPRIC TRIGLYCERIDE, LAUROYL LYSINE, FRAGRANCE, PEG-8, PENTAERTHRITYL TETRA-DI-T-BUTYL
    HYDROXYHDROCINNAMATE, TOCOPHEROL, ORCHID (CYMBIDIUM GRANIFLORUM) FLOWER EXTRACT, ASCORBYL PALMITATE, ASCORBIC ACID, CITRIC ACID, D& C RED NO. 28 ALUMINUM LAKE.

  • KOSAN KOZMETIK SANAYI VE TICARET A.S.

    GEBZE ORGANIZE SANAYI BOLGESI IHSAN DEDE CAD.900.SK NO:133 GEBZE, KOCAELI 41480 TURKEY
    MADE IN TURKEY
    WWW.FLORMAR.COM
    TO REPORT A SERIOUS ADVERSE EVENT
    CONTACT [971] 766 – 7350.    WITH ULTRA-RICH AND INTENSE COLOR, THIS SPF 15 SUNSCREEN LIPSTICK LEAVES THE LIPS FEELING
    COMFORTABLE. EXPERIENCE THIS CREAMY TEXTURE AND HIGH COMFORT. APPLY ON THE CENTER OF THE LIPS AND BLEND.

  • Product Labels

    flormar Delicious Lipstick Style Sunscreen Broad Spectrum SPF 15  Net Wt. 0.11 oz (3g)

    flormarLipstikc_Outer

    flormarLipstikc_Inner

  • INGREDIENTS AND APPEARANCE
    FLORMAR DELICIOUS LIPSTICK STYLO SUNSCREEN BROAD SPECTRUM SPF 15 DS03 DOLL PHOTOMONTAGE 
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61722-230
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICA (UNII: V8A1AW0880)  
    TRIISOSTEARYL CITRATE (UNII: 50XT325OOH)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    PENTAERYTHRITYL TETRABEHENATE (UNII: 9MNZ044IRY)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61722-230-001 in 1 BOX12/17/2014
    13 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/17/2014
    Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)