Label: SUNTONE BROAD SPECTRUM SPF 4- octinoxate spray

  • 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 17, 2020

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  • Active ingredients

    Octinoxate 2 %

  • PURPOSE

    Purpose

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

  • Directions

    • apply liberally 15 minutes before sun exposure.
    • do not spray directly into face. Spray on hands then apply to face
    • reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hour
    • children under 6 months: ask a doctor.

  • Inactive Ingredients

    Aloe Barbadensis Extract, Cocos Nucifera (Coconut) Oil, Fragrance (Parfum), Mineral Oil (Paraffinum Liquidum), Propylparaben, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate

  • Other information

    • protect this product from excesive heat and direct sun.
    • avoid spraying on fabrics - could cause discoloration

  • QUESTIONS

    Questions or Comments?

    Biocycle Laboratories, Inc.

    16363 NW 49 Avenue

    Miami, FL 33014

  • PRINCIPAL DISPLAY PANEL - 236 mL  Bottle Label

    PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

    Suntone

    Fit for the Sun

    DARK TANNING

    Sunscreen Spray Oil

    SPF 4

    Water Resistant

    (80 Minutes)

    4

    Contains Aloe Vera

    8 FL. OZ./236mL

  • INGREDIENTS AND APPEARANCE
    SUNTONE  BROAD SPECTRUM SPF 4
    octinoxate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0098
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE16.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0098-4236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/18/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/18/2013
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0098) , pack(58443-0098) , manufacture(58443-0098) , analysis(58443-0098)
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