Label: FLORMAR BB SHEER TINTED BEAUTY SUNSCREEN BROAD SPECTRUM SPF 15 02 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

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  • flormar BB Cream Sheer Tinted Beauty Sunscreen Broad Spectrum SPF 15 02 Light Medium


  • 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

    • Wear alone or under foundation.
    • 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.
    • Keep the product cool.
    • After use, close the tube properly with cap.
  • Inactive ingredients

    water, cyclopentasiloxane, butylene glycol, ethylhexyl methoxycinnamate, polysilicone-11, cetyl PEG/PPG-10/1 dimethicone, dimethicone, PEG-10 dimethicone, trimethylsiloxysilicate, disteardimonium hectorite, glycerin, SD alcohol 40-B, polymethylsilsesquioxane, phenoxyethanol, methy methacrylate cross-polymer, sodium chloride, fragrance, sodium PCA, ethylhexylglycerin, urea, triethoxycaprylylsilane, algae extract, laureth-12, soluble collagen, aluminum hydroxide, trehalose, leuconostoc/radish root ferment filtrate, polyquaternium-51, sodium hyaluronate, chlorphenesin, propylene glycol, fig (Ficus carica) fruit extract, cotton (Gossypium hirsutum) seed extract, linseed (Linum usitatissimum) seed extract, sodium dehydroacetate, caprylyl glycol, hexyl cinnamal, benzyl salicylate, butylphenyl methylpropional, alpha-isomethyl ionone, linalool.
    may contain: titanium dioxide, iron oxides.

  • flormar BB Cream Sheer Tinted Beauty Sunscreen Broad Spectrum SPF 15 02 Light Medium 40ml (61722-002-00)

    BB Cream Label

    BBCreamLabel2

  • INGREDIENTS AND APPEARANCE
    FLORMAR BB SHEER TINTED BEAUTY SUNSCREEN BROAD SPECTRUM SPF 15 02 LIGHT MEDIUM 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61722-002
    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 (UNII: 92RU3N3Y1O)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    UREA (UNII: 8W8T17847W)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    LAURETH-12 (UNII: OAH19558U1)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TREHALOSE (UNII: B8WCK70T7I)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FIG (UNII: TGD87RII2U)  
    COTTON SEED (UNII: DI0ZRJ0MXN)  
    FLAX SEED (UNII: 4110YT348C)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61722-002-001 in 1 BOX06/12/2014
    140 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 finalpart35206/12/2014
    Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)
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