Label: SUNSCREEN WITH ALOE VERA SPF 30- octinoxate, octisalate, and oxybenzone lotion

  • NDC Code(s): 73563-011-01, 73563-011-18
  • Packager: Body One Products, Inc.
  • 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 31, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Octinoxate 7.5%Sunscreen
    Octisalate 5.0%Sunscreen
    Oxybenzone 6.0%Sunscreen
  • Uses

    *
    Helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Aging Alert

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    For external use only

    Do Not Use on damaged skin 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

    *
    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.
  • Other Information

    Protect this product container from excessive heat and direct sun.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Brassica Campestris/Aleurites Fordi Oil Copolymer, Butyl Paraben, Carbomer, Dimethicone, Ethylparaben, Fragrance,Glyceryl Stearate SE, Isobutylparaben, Lanolin Alcohol, Methylparaben,Mineral Oil, Phenoxyethanol, Propylparaben, Stearic Acid , Water.

  • Questions or Comments?

    Call 1-800-544-8800

  • PRINCIPAL DISPLAY PANEL - 532 ML Bottle Label

    BodyOne
    Products

    SUN SCREEN

    SPF 30 LOTION

    (18 FL.OZ. 532ML)

    Principal Display Panel - 532 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    SUNSCREEN WITH ALOE VERA SPF 30 
    octinoxate, octisalate, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73563-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Allantoin (UNII: 344S277G0Z)  
    Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked) (UNII: Z135WT9208)  
    GULOSE, L- (UNII: J96E9Q45N7)  
    Mineral Oil (UNII: T5L8T28FGP)  
    HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Aloe vera leaf (UNII: ZY81Z83H0X)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Glyceryl Stearate SE (UNII: FCZ5MH785I)  
    Cetostearyl alcohol (UNII: 2DMT128M1S)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73563-011-013785 mL in 1 JUG; Type 0: Not a Combination Product02/01/2020
    2NDC:73563-011-18532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35202/01/2020
    Labeler - Body One Products, Inc. (117376115)
    Registrant - BMC 1092,Inc dba Solo Laboratories Inc. (078831987)
    Establishment
    NameAddressID/FEIBusiness Operations
    BMC 1092,Inc dba Solo Laboratories Inc.078831987MANUFACTURE(73563-011)
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