Label: FLORMAR REBORN DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10- 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 REBORN DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10


  • Active ingredient

    Octinoxate 5%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
    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.

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

  • Directions

    • Use all over face or to enlighten your chest area or shoulders.
    • 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.
  • Other information

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

    water, cyclopentasiloxane, isododecane, mica, butylene glycol, dimethicone, PEG-10 dimethicone, trimethylsiloxysilicate, polymethylsilsesquioxane, glycerin, phenoxyethanol, polysilicone-11, disteardimonium hectorite, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, polyglyceryl-4 isostearate, sodium chloride, triethoxycaprylylsilane, propylene carbonate, ethylhexylglycerin, algae extract, disodium EDTA, fragrance, laureth-12, chlorphenesin, propylene glycol, tea (Camellia sinensis) leaf extract, maté (Ilex paraguariensis) leaf extract, guarana (Paullinia cupana) seed extract, sodium dexydroacetate, titanium dioxide, iron oxides.

  • flormar REBORN DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10 30ml (61722-023-00)

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  • INGREDIENTS AND APPEARANCE
    FLORMAR REBORN DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61722-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    MICA (UNII: V8A1AW0880)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LAURETH-12 (UNII: OAH19558U1)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    PAULLINIA CUPANA SEED (UNII: C21GE7524R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61722-023-001 in 1 BOX06/16/2014
    130 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/16/2014
    Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)
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