FRUIT OF THE EARTH SPORT SPF 50 SUNSCREEN CONTINUOUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, SPRAY [FRUIT OF THE EARTH, INC.]

FRUIT OF THE EARTH SPORT SPF 50 SUNSCREEN CONTINUOUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, SPRAY [FRUIT OF THE EARTH, INC.]
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NDC 62217-012-35
Set ID 4fa69e1b-fd2e-302e-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Fruit of the Earth, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 4.0%, Oxybenzone 5.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn • higher SPF gives more sunburn protection

  • Warnings

    ​For external use only

  • FLAMMABLE:

    • do not use near heat, flame or while smoking
    • avoid long term storage above 104°F (40°C)

  • DO NOT USE

    Do not use • on damaged or broken skin.

  • WHEN USING

    ​When using this product • keep out of eyes. Rinse with water to remove. • keep away from
    face to avoid breathing it in. • do not puncture or incinerate. Contents under pressure. • do not
    store at temperatures above 120° F.

  • STOP USE

    ​Stop use and ask doctor if

    • rash occurs.
  • KEEP OUT OF REACH OF CHILDREN

    ​Keep out of reach of children. ​If product is swallowed, get medical help right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • hold can 4-6 inches away from body, spray evenly to ensure
    complete coverage
    • do not spray into face. Spray into hand and apply to face.
    • use in well ventilated, but not windy areas
    • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    Sun Protection Measures. Spending time in the sun increases
    your risk of skin cancer and early skin aging. To decrease this risk,
    regularly use a sunscreen with a broad-spectrum SPF of 15 or
    higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: ask a doctor

  • Other information

    • protect this product from excessive heat and direct sun
    • may stain or damage some fabrics, materials or surfaces

  • Inactive ingredients

    alcohol denat. (73.2% v/v), acrylates/octylacrylamide copolymer,
    stearoxytrimethylsilane, glycerin, diethylhexyl syringylidenemalonate,
    tocopherol (vitamin E), ascorbic acid (vitamin C), aloe barbadensis
    leaf juice, fragrance (parfum), caprylic/capric triglyceride

  • Questions or comment?

    Call toll free 1-800-527-7731

  • Fruit of the Earth, Inc. Sport SPF 50 Sunscreen Continuous Spray

    Representative Image

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH  SPORT SPF 50 SUNSCREEN CONTINUOUS
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE40 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    ALCOHOL (UNII: 3K9958V90M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-012-35148 mL in 1 CAN; Type 0: Not a Combination Product05/16/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/16/2017
    Labeler - Fruit of the Earth, Inc. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(62217-012)

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