Label: FRUIT OF THE EARTH, INC. LUV THAT SUN KIDS SPF 50 NATURAL SUNSCREEN- avobenzone, homosalate, octocrylene lotion

  • NDC Code(s): 62217-003-15
  • 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

    Avobenzone 3.0%, Homosalate 10.0%, Octocrylene 6.0%

  • 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, Cetearyl Alcohol, Stearyl Alcohol, Glycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Cetyl Alcohol, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Xanthan Gum, Disodium EDTA, Hydrogenated Methyl Abiete, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate, Copolymer, Sodium Ascorbyl Phosphate, 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, Polysorbate 20, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Triethanolamine, Propylene Glycol, Hydroxyacetophenone.

  • PRINCIPAL DISPLAY PANEL

    Fruit of the Earth

    Luv that Sun

    Kids Natural Lotion Sunscreen

    Broad Spectrum SPF 50

    6.0 FL OZ (177 ML)

    Label

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH, INC.  LUV THAT SUN KIDS SPF 50 NATURAL SUNSCREEN
    avobenzone, homosalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ADANSONIA DIGITATA FRUIT (UNII: 51N9TR1W6P)  
    WATERMELON (UNII: 231473QB6R)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PHRAGMITES AUSTRALIS STEM (UNII: 3AW23L82V4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SCUTELLARIA ALPINA FLOWERING TOP (UNII: 68JZ9NK55M)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
    LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)  
    FU LING (UNII: XH37TWY5O4)  
    APPLE (UNII: B423VGH5S9)  
    TRIFOLIUM PRATENSE LEAF (UNII: 612YOZ36DG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-003-15177 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(62217-003)
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