MAKETA SUNSCREEN WITH ALOE VERA SPF 30 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [MAKÉTA™ SUNSCREEN LOTION WITH ALOE VERA SPF 30]

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  • MAKETA SUNSCREEN WITH ALOE VERA SPF 30 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [MAKÉTA™ SUNSCREEN LOTION WITH ALOE VERA SPF 30]

MAKETA SUNSCREEN WITH ALOE VERA SPF 30 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [MAKÉTA™ SUNSCREEN LOTION WITH ALOE VERA SPF 30]
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NDC 72102-047-06, 72102-047-18
Set ID 1a8a50aa-78ac-4875-9bc1-fb8cee691527
Category HUMAN OTC DRUG LABEL
Packager Makéta™ Sunscreen Lotion with Aloe Vera SPF 30
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients:Purpose
    Octinoxate7.5%Sunscreen
    Octisalate5.0%Sunscreen
    Oxybenzone6.0%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 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 from excessive heat and direct sun.

  • Inactive Ingredients

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

  • SPL UNCLASSIFIED SECTION

    Distributed By Makéta, LLC • Chicago, Illinois

  • PRINCIPAL DISPLAY PANEL - 532 ml Bottle Label

    SPF 30

    ALOE

    Makéta™
    sunscreen
    LOTION

    Aloe Vera
    Sun Screen Lotion

    NET WT. 18 FL. OZ. (532 ml)

    Makéta, LLC

    PRINCIPAL DISPLAY PANEL - 532 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    MAKETA SUNSCREEN WITH ALOE VERA SPF 30 
    octinoxate, octisalate, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72102-047
    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:72102-047-06177 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2018
    2NDC:72102-047-18532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35206/01/2018
    Labeler - Makéta™ Sunscreen Lotion with Aloe Vera SPF 30 (081031516)
    Establishment
    NameAddressID/FEIBusiness Operations
    BMC 1092, Inc. dba Solo Laboratories, Inc078831987MANUFACTURE(72102-047) , LABEL(72102-047)
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