Label: FRUIT OF THE EARTH, INC. LUV THAT SUN SPF 30 NATURAL MINERAL SUNSCREEN- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 62217-001-13
  • 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 February 6, 2018

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  • Active ingredients

    Titanium Dioxide 3.1%, Zinc Oxide 4.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
  • Warnings

    For external use only

  • When using this product

    • keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if

    • if rash or irritation develops and last.
  • Keep out of reach of children.

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

  • Directions

    • apply generously and evenly 15 minutes before sun exposure
    • reapply as needed or:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • children under 6 months: ask a doctor

  • Other information

    • may stain or damage some fabrics, materials or surfaces
    • Sun Protection Measures. Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risks of aging, skin cancer, and other harmful effects of the sun.
  • Inactive ingredients

    Water, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Octyldodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1, Dimethicone, Lauryl PEG-8 Dimethicone, Glycerin, Aloe Barbadensis, Leaf Juice, Sodium Chloride, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Ethylhexyl Methoxycrylene, Dimethicone, Caprylyl Glycol, PEG-8, Silica, Phenoxyethanol, Triethoxycaprylylsilane, Sodium Citrate, Tocopheryl Acetate, Adansonia Digitata Fruit Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Hibiscus Sabdariffa Flower Extract, Lens Esculenta (Lentil) Fruit Extract, Phragmites Communis Extract, Polysorbate 20, Pyrus Malus (Apple) Fruit Extract, Poria Cocos Extract, Scutellaria Alpina Flower/Leaf/Stem Extract, Trifolium Pratense (Clover) Leaf Extract.

  • PRINCIPAL DISPLAY PANEL

    Fruit of the Earth

    Luv that Sun

    Natural Mineral Sunscreen Lotion

    Broad Spectrum SPF 30

    Label

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH, INC.  LUV THAT SUN SPF 30 NATURAL MINERAL SUNSCREEN
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40.4625 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE31.16 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PHRAGMITES AUSTRALIS STEM (UNII: 3AW23L82V4)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    SCUTELLARIA ALPINA FLOWERING TOP (UNII: 68JZ9NK55M)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)  
    FU LING (UNII: XH37TWY5O4)  
    APPLE (UNII: B423VGH5S9)  
    TRIFOLIUM PRATENSE LEAF (UNII: 612YOZ36DG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ADANSONIA DIGITATA FRUIT (UNII: 51N9TR1W6P)  
    WATERMELON (UNII: 231473QB6R)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-001-13100 mL in 1 TUBE; Type 0: Not a Combination Product02/06/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/06/2018
    Labeler - Fruit of the Earth, Inc. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(62217-001)
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