Label: HILL COUNTRY ESSENTIALS- spf 15 moisturizing lotion

  • 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 March 9, 2020

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  • Active ingredients

    Avobenzone 3.0%, Octisalate 2.0%, Octinoxate 7.5%

  • 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

  • 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. 

  • ASK DOCTOR

    Stop use and ask a doctor if • rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply 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 of age: 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

    water, C12-C15 alkyl benzoate, glycerin, cetearyl alcohol, dimethicone, glycine soja (soybean) seed extract, bis-phenylpropyl dimethicone, arachidyl alcohol, phenoxyethanol, cetearyl glucoside, panthenol, benzyl alcohol, ethylene/acrylic acid copolymer, behenyl alcohol, steareth-2, fragrance, steareth-21, polyacrylamide, polymethyl methacrylate, arachidyl glucoside, disodium EDTA, methylparaben, C13-14 isoparaffin, ethylparaben, butylparaben, laureth-7, benzalkonium chloride, propylparaben, isobutylparaben, iodopropynyl butylcarbamate, BHT, PEG-4 dilaurate, PEG-4 laurate, PEG-4, mica, silica, titanium dioxide

  • Questions or comments?

    Call toll free 1-800-527-7731

  • PRINCIPAL DISPLAY PANEL

    Hill Country Essentials Radiant Skin SPF 15 Moisturizing Lotion

    4 FL OZ (120mL)

    NDC 37808-985-04

    LabelBlisterPack

  • INGREDIENTS AND APPEARANCE
    HILL COUNTRY ESSENTIALS 
    spf 15 moisturizing lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-985
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE20 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    MICA (UNII: V8A1AW0880)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    BIS-PHENYLPROPYL DIMETHICONE (15 CST) (UNII: 4836494CFT)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)  
    LAURETH-7 (UNII: Z95S6G8201)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    PEG-4 DILAURATE (UNII: KCR71CW036)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-985-051 in 1 CARTON07/09/2011
    1NDC:37808-985-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/09/2011
    Labeler - H.E.B (007924756)
    Registrant - Fruit of the Earth, Inc. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit of the Earth, Inc.008193513manufacture(37808-985)
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