SUNSCREEN WITH ALOE VERA SPF 30 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [FORE SUPPLY, INC]

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  • SUNSCREEN WITH ALOE VERA SPF 30 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [FORE SUPPLY, INC]

SUNSCREEN WITH ALOE VERA SPF 30 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [FORE SUPPLY, INC]
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NDC 71627-116-01, 71627-116-18
Set ID c59dd763-ccad-4222-b36e-35caa46ab324
Category HUMAN OTC DRUG LABEL
Packager Fore Supply, Inc
Generic Name
Product Class
Product Number
Application Number PART352
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  • Purpose

    Sunscreen

  • ACTIVE INGREDIENT

    Active Ingredients Purpose
    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, FragranceGlyceryl Stearate SE, Isobutylparaben, Lanolin Alcohol, Methylparaben,Mineral Oil, Phenoxyethanol, Propylparaben, Stearic Acid , Water.

  • Questions or Comments?

    Call 1-800-543-5430

  • PRINCIPAL DISPLAY PANEL

    sunscreen-01

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN WITH ALOE VERA SPF 30 
    octinoxate, octisalate, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71627-116
    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:71627-116-013785 mL in 1 JUG; Type 0: Not a Combination Product10/02/2017
    2NDC:71627-116-18532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/02/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35210/02/2017
    Labeler - Fore Supply, Inc (025126459)
    Registrant - Fore Supply, Inc (025126459)
    Establishment
    NameAddressID/FEIBusiness Operations
    HealthSpecialty794053863MANUFACTURE(71627-116)
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