Label: FLORMAR RADIANT PINK SKIN HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octinoxate, octocrylene 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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  • Drug facts


  • Active Ingredient

    Avobenzone 3%

    Octinoxate 7.5%

    Octocrylene 1%

    Purpose

    sunscreen

  • Uses

    • Helps prevent sunburn.
    • If used as direct 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 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

    • Apply alone or as a thin layer under foundation.
    • 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 Bord 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
  • SPL UNCLASSIFIED SECTION

  • Inactive ingredients

    WATER,CYCLOPENTASILOXANE, BUTYLENE GLYCOL, SYNTHETIC FLUORPHLOGOPITE, ISOCETYL STEAROYL STEARATE, CETEARYL OLIVATE,
    DIMETHICONE, CETEARYL ALCOHOL, SORBITAN OLIVATE, POLYGLYCERYL-3 POLYDIMETHYL SILOXYETHYL DIMETHICONE, PHENOXYETHANOL, PANTHENOL, STEARIC ACID, SACCHARIDE ISOMERATE, FRAGRANCE, SILICA, PHENYLPROPANOL, CAPRYLYL GLYCOL, PROPANEDIOL, ETHYLHEXYLGLYCERIN, TIN OXIDE, CITRIC ACID, SODIUM CITRATE, TRIETHOXYCAPRYLYLSILANE, TOCOPHEROL, TITANIUM DIOXIDE, IRON OXIDES.

  • Peel away for Drug Facts

    This soft formula with a blend of unique pink pearls helps dull skin appear brighter for a perfect look.  Apply alone or as a thin layer under foundation.  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

  • PRINCIPAL DISPLAY PANEL

    Flormar  RADIANT PINK SKIN HIGHLIGHTER SUNSCREEN CREAM BROAD SPECTRUM SPF 15  0.61 FL oz (18 ml)

  • Product Label

    FlormarRadiantPink

    BoxLabel

  • INGREDIENTS AND APPEARANCE
    FLORMAR RADIANT PINK SKIN HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 15 
    avobenzone, octinoxate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61722-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61722-220-001 in 1 CARTON11/07/2014
    118 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 finalpart35211/07/2014
    Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)
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