Label: BB CREAM SPF 20 NUDE- octinoxate, octisalate, oxybenzone cream

  • Category: HUMAN OTC DRUG LABEL

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 December 17, 2020

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  • Drug Facts

  • Active ingredients

    Octinoxate 6.0%

    Octisalate 4.0%

    Oxybenzone 3.5%

  • 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

    For sunscreen 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 sun 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 shirt, pants, hats and sunglasses
      • children under 6 months of age: Ask doctor.
  • Inactive ingredients

    Water (Aqua), Glycerin, Propylene Glycol, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Cydopentasiloxane, Cyclohexasiloxane, Sorbitan Olivate, Polymethyl Methacrylate, Sodium Chloride, Quatemium-18 Bentonite, Quartz, Triethoxycaprylylsilane, Zinc Stearate, Talc, Vp/Hexadecene Copolymer, Bisabolol, Tocopheryl Acetate (Ve), Simmondsia Chinensis (Jojoba) Seed Oil, Aloe Barbadensis Leat Extract, Cucumis Sativus (Cucumber) Fruit Extract, Mica, Silica, Butylene Glycol, Phenoxyethanol, Ethylhexylglycerin, Caprylyl Glycol, Fragrance (Parfum) May Contain: Iron Oxides (Cl 77491, Cl 77492, Cl 77499), Titanium Dioxide (Cl 77891)

  • Questions or comments?

    1-855-353-7320

  • Principal Display Panel - 28.5 mL Carton Label

    e.l.f.

    BB CREAM

    SPF 20
    sunscreen

    NUDE

    NET 0.96 FL. OZ. (28.5mL)

    Principal Display Panel - 28.5 mL Carton Label
  • INGREDIENTS AND APPEARANCE
    BB CREAM SPF 20 NUDE 
    octinoxate, octisalate, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-862
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE35 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICA (UNII: V8A1AW0880)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENTOQUATAM (UNII: 7F465U79Q1)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    TALC (UNII: 7SEV7J4R1U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CUCUMBER (UNII: YY7C30VXJT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76354-862-0128.5 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/18/2018
    Labeler - J. A. Cosmetics U.S. INC (186705047)
    Establishment
    NameAddressID/FEIBusiness Operations
    Columbia Cosmetics Manufacturing, Inc.068267863manufacture(76354-862)
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