Label: PRETTY BY FLORMAR BB 002 LIGHT MEDIUM- 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

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

  • Drug Facts

  • Active ingredient

    Octinoxate 5%

    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 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

    • Shake well before use.
    • After use, close the cap properly.
    • 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.
    • Keep the product cool.
    • After use, close the tube properly with cap.
  • Inactive ingredients:

    water, cyclopentasiloxane, butylene glycol, polysilicone-11, cetyl PEG/PPG-10/1 dimethicone, dimethicone, PEG-10 dimethicone, trimethylsiloxysilicate, disteardimonium hectorite, SD alcohol 40-B, polymethylsilsesquioxane, phenoxyethanol, methyl methacrylate
    crosspolymer, glycerin, sodium chloride, fragrance, ethylhexylglycerin, tocopheryl acetate, triethoxycaprylylsilane, aluminum hydroxide,
    laureth-12, fig (ficus carica) fruit extract, cotton (gossypium hirsutum) seed extract, linseed (linum usitatissimum) seed extract, caprylyl glycol, hexyl cinnamal, benzyl salicylate, butylphenyl methylpropional, alpha-isomethyl ionone, linalool. may contain: titanium dioxide, iron oxides.

  • Package Labeling:

    Drug Facts ContinuedShade NameBB CreamSPF 15

  • INGREDIENTS AND APPEARANCE
    PRETTY BY FLORMAR BB 002 LIGHT MEDIUM 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61722-301
    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)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    LAURETH-12 (UNII: OAH19558U1)  
    COTTON SEED (UNII: DI0ZRJ0MXN)  
    FLAX SEED (UNII: 4110YT348C)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61722-301-001 in 1 BOX06/17/2017
    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 finalpart35206/17/2017
    Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)