Label: FRUIT OF THE EARTH, INC. LUV THAT SUN SPF 30 CONTINUOUS- avobenzone, homosalate, octisalate, octocrylene aerosol, spray

  • NDC Code(s): 62217-827-25
  • Packager: Fruit of the Earth, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 21, 2022

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  • Active ingredients

    Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 2.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see ​Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • 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 ​​

    on damaged or broken skin

  • When using this product

    • keep out of eyes. Rinse with water to remove. • do not puncture

    or incinerate. Contents under pressure. • do not store at temperatures above 120° F.

  • ​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
    • 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 value 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-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor

  • Other information

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

  • Inactive ingredients

    SD Alcohol 40-B, Butyloctyl Salicylate, Acrylates/Octylacrylamide
    Copolymer, Hibiscus Sabdariffa Flower Extract, Pyrus Malus (Apple) Fruit
    Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Lens Esculenta
    (Lentil) Fruit Extract, Adansonia Digitata Fruit Extract, Scutellaria Alpina
    Flower/Leaf/Stem Extract, Trifolium Pratense (Clover) Leaf Extract,
    Phragmites Communis Extract, Poria Cocos Extract, Camellia Sinensis
    (Green Tea) Leaf Extract, Panthenol, Tocopherol, Fragrance, Diethylhexyl
    Syringylidenemalonate, Stearoxytrimethylsilane, Caprylic/Capric
    Triglyceride, Water, Glycerin, Polysorbate 20, Phenoxyethanol.

  • Label

    RepresenativeImage

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH, INC.  LUV THAT SUN SPF 30 CONTINUOUS
    avobenzone, homosalate, octisalate, octocrylene aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-827
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 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
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ADANSONIA DIGITATA FRUIT (UNII: 51N9TR1W6P)  
    FU LING (UNII: XH37TWY5O4)  
    APPLE (UNII: B423VGH5S9)  
    TRIFOLIUM PRATENSE LEAF (UNII: 612YOZ36DG)  
    ALCOHOL (UNII: 3K9958V90M)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    WATERMELON (UNII: 231473QB6R)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)  
    PHRAGMITES AUSTRALIS STEM (UNII: 3AW23L82V4)  
    SCUTELLARIA ALPINA FLOWERING TOP (UNII: 68JZ9NK55M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-827-25177 mL in 1 CAN; Type 0: Not a Combination Product03/03/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/03/2016
    Labeler - Fruit of the Earth, Inc. (079559467)
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