Label: BFF SKIN PERFECTOR SPF 30 BROAD SPECTRUM SUNSCREEN LIGHTEST- avobenzone, homosalate, octisalate lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 12, 2022

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

  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Avobenzone 2.5% Sunscreen

    Homosalate 9.0% Sunscreen

    Octisalate 4.5% Sunscreen

  • PURPOSE

    Uses

    • Helps prevent Sunburn
    • Higher SPF gives more sunburn protection
    • Provides high protection against 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
  • KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Stop use and ask a doctor

    • if rash occurs
  • WARNINGS

    Warnings

    For external use only

    Do not use

    • On damaged or broken skin

    When using this product

    • Keep out of eyes. In case of contact, rinse immediately with water
  • DOSAGE & ADMINISTRATION

    Directions

    • Apply Liberally 15 minutes before sun exposure
    • Children under 6 months of age: ask a doctor
    • For sunscreen use apply to all skin exposed to the sun
    • 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 suncreen 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
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Aqua (water), Steareth-2, C9-12 Alkane, Steareth-21, Glycerin, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Dimethicone, Propanediol, Maltodextrin, 1,2-Hexanediol, Boron Nitride, Sodium Stearoyl Glutamate, Diethylhexyl Syringylidenemalonate, Parfum (Fragrance), Fucus Vesiculosus (Seaweed) Extract, Cocos Nicifera (Coconut) Fruit Extract, Coco-Caprylate/Caprate, Synthetic Fluorphlogopite, Xanthan Gum, Potassium Sorbate, Lecithin, Caffeyl Glucoside, Rosmarinyl Glucoside, Gallyl Glucoside, Succinic Acid, Caprylhydroxamic Acid, Dimethylmethoxy Chromanol, Zein, Zea Mays (Corn) Starch, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Silica Dimethyl Silylate, Ascorbyl Palmitate, Hexylene Glycol, Caprylyl Glycol, Tocopherol, Citric Acid, Linalool*[+/-],

    CI 77891 (Titanium Dioxide), CI 77492 (Iron Oxides), CI 77491 (Iron Oxides), CI 77499 (Iron Oxides)

  • OTHER SAFETY INFORMATION

    Other Information

    • Protect the product in this container from excessive heat and direct
  • PRINCIPAL DISPLAY PANEL

    Trinny London

    BFF SPF 30 skin perfector SPF 30 broad spectrum sunscreen

    lightest 30 ml

    Carton Skin perfector 30

    Lightest bff spf 30

  • INGREDIENTS AND APPEARANCE
    BFF SKIN PERFECTOR SPF 30 BROAD SPECTRUM SUNSCREEN LIGHTEST 
    avobenzone, homosalate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82439-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STEARETH-21 (UNII: 53J3F32P58)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    .BETA.-GLUCOGALLIN (UNII: 4X7JGS9BFY)  
    ZEIN (UNII: 80N308T1NN)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STEARETH-2 (UNII: V56DFE46J5)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    SUCCINIC ACID (UNII: AB6MNQ6J6L)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    COCONUT (UNII: 3RT3536DHY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82439-101-0130 mL in 1 BOX; Type 0: Not a Combination Product01/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/14/2022
    Labeler - Trinny London Ltd (219991462)