Label: RIMMEL BB BEAUTY BALM MEDIUM DARK- avobenzone, octinoxate, octisalate and octocrylene liquid

  • 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, 2012

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

  • Drug Facts

    Avobenzone 3%

    Octinoxate 4%

    Octisalate 4%

    Octocrylene 2%

  • PURPOSE

    Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    • 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.

  • DOSAGE & ADMINISTRATION

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours

    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 value of 15 SPF or higher and other sun protection measures including:

    • Limit tim in the sun, especially from 10 a.m-2p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
    • Children under 6 months of age: ask a doctor.
  • INACTIVE INGREDIENT

    Aqua/Water/Eau, Dicaprylyl Carbonate, Mica, Cyclopentasiloxane, Glycerin, Behenyl Alcohol, Alcohol, Isodecyl Neopentanoate, Butyrospermum Parkii (Shea) Butter, Methyl Methacrylate Crosspolymer, Beheneth-25, Glyceryl Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aluminum Dimyristate, Ascorbyl Glucoside, BHT, Citric Acid, Disodium Stearoyl Glutamate, Clycyrrhiza Glabra (Licorice) Root Extract, Pentylene Glycol, Tetrasodium EDTA, Tocopherol, Triethoxycarpylylsilane, Xanthan Gum, Phenoxyethanol, Parfum/Fragrance, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    RIMMEL BB BEAUTY BALM  MEDIUM DARK
    avobenzone, octinoxate, octisalate and octocrylene liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76485-1026
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.9 mL  in 30 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.2 mL  in 30 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.2 mL  in 30 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.6 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    METHYL METHACRYLATE (UNII: 196OC77688)  
    BEHENETH-25 (UNII: 0G17KJ5M7P)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76485-1026-130 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/15/2012
    Labeler - Rimmel Inc. (949791073)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lancaster S.A.M.401011325manufacture(76485-1026)