Label: MARIO BADESCU ALOE SPF- avobenzone, octinoxate, oxybenzone 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 2.0%
    Octinoxate 7.5%
    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 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 aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protectionmeasures 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), Aloe Barbadensis Leaf Juice, Aluminum Starch Octenylsuccinate, Glycerin, Ethylhexyl Methoxycrylene, Isopropyl Myristate, Cetyl Alcohol, Dimethicone, PPG-2 Myristyl Ether Propionate, Stearic Acid, Styrene/Acrylates Copolymer, Caprylyl Glycol, PEG-8 Laurate, Ceteareth-20, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Carbomer, Tetrasodium Glutamate Diacetate, Ethylhexlglycerin, Sodium Hydroxide, Phenoxyethanol, Cl 42090 (Blue 1 )

  • 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 SKIN CARE Aloe Moisturizer SPF 15 SUNSCREEN product label

    MARIO
    BADESCU
    SKIN CARE
    Established 1967
    MB
    Aloe
    Moisturizer
    BROAD SPECTRUM
    SPF15 SUNSCREEN

    2 fl oz  (59 ml)

    Effectively hydrate while protecting your skin against harmful UVA/UVB rays. Perfect for troubled or sensitive, oily skin, this light weight, Aloe-enriched moisturizer absorbs quickly to deliver an instant boost of hydration without the pore-clogging oils.

    Made in the USA. 72072-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

    Bently MarioBadescu 137

  • INGREDIENTS AND APPEARANCE
    MARIO BADESCU ALOE SPF 
    avobenzone, octinoxate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-137
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.2 g  in 59 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4.24 g  in 59 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.0 g  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54111-137-5129 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/04/2017
    2NDC:54111-137-5059 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/04/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/04/2017
    Labeler - Bentley Laboratories LLC (068351753)
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