Label: MARIO BADESCU SPF 30- avobenzone, octinoxate, octisalate, octocrylene 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 December 19, 2018

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  • Drug FactsActive ingredients

    Avobenzone 3.0%
    Octinoxate 7.5%
    Octisalate 5.0%
    Octocrylene 10.0%

  • 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 aging caused by the sun.
  • Warnings

    For external use only.

    Do not use on damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

    When using this product keep out of eyes. Rinse with water to remove

  • Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • use a water-resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: Ask a doctor

    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.
  • Inactive ingredients

    Aqua (Water, Eau), Glycerin, Aluminum Starch Octenylsuccinate, Dimethicone, Cetearyl Alcohol, Ethylhexyl Methoxycrylene, PPG-2 Myristyl Ether Propionate, C12-15 Alkyl Benzoate, Ceteareth-20, Sorbitan Oleate, Aloe Barbadensis Leaf Juice, Camellia Oleifera Leaf Extract, Hypericum Perforatum Leaf Extract, Ethylhexlglycerin, Tetrasodium Glutamate Diacetate, PEG-100 Stearate, Caprylyl Glycol, Carbomer, Parfum (Fragrance), Phenoxyethanol, Sodium Hydroxide

  • Other information

    Protect this product from excessive heat and direct sun.

  • Questions or comments?

    Call 1-800-223-3728 M - F 9 a.m. - 5 p.m. EST or visit mariobadescu.com

  • Mario Badescu Oil Free Moisturizer SPF 30 product label

    MARIO
    BADESCU
    SKIN CARE
    Established 1967
    MB
    OIL FREE
    MOISTURIZER
    BROAD SPECTRUM
    SPF 30 SUNSCREEN

    SKIN TYPES - C, O, S,

    2 fl oz (59 ml)

    Moisturize skin with antioxidant-packed hydration. Enhanced with Green Tea and St John's Wort to prevent premature signs of aging, this best- selling formula delivers lasting moisture and essential broad spectrum protection to encourage a smoother dewier complexion,

    Made in the USA. 71849-J001
    CRUELTY FREE l PARABEN FREE
    Mario Badescu Skin Care, New York, NY • (800) BADESCU
    Leceur Plaza 1 Salford M50 3UB, UK

    order online at mario bedescu.com

    Bentley MarioBadescu 134

  • INGREDIENTS AND APPEARANCE
    MARIO BADESCU SPF 30 
    avobenzone, octinoxate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-134
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 59 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 g  in 59 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 g  in 59 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54111-134-5059 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/01/2017
    Labeler - Bentley Laboratories LLC (068351753)
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