Label: HOPE IN A JAR FOR DRY SKIN SPF BROAD SPECTRUM SPF 20 SUNSCREEN AND EXTRA-RICH MOISTURIZER FOR NORMAL TO DRY SKIN- avobenzone, octinoxate, and oxybenzone cream

  • 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 July 8, 2013

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  • ACTIVE INGREDIENT

    Active Ingredients

    Avobenzone (2.0%)......Sunscreen

    Octinoxate (7.0%)........Sunscreen

    Ozybenzone (2.5%)......Sunscreen

  • PURPOSE


    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

    Warnings

    For external use only.

    Do not use on damaged or broken skin.

    When using this product keep our of eyes.

    Rinse with water to remove.

    Stop use and ask a doctor if a rash occurs.

  • DOSAGE & ADMINISTRATION

    Directions

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • 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
  • 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.

  • OTHER SAFETY INFORMATION

    Other Information

    • protect this product from excessive heat and direct sun
  • Questions or Comments?

    Call toll-free 1-800-568-3151 from 6 a.m.-5 p.m. MST (Monday-Friday)

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water (aqua), butyloctyl salicylate, behenoxy dimethicone, glycerin, behinic acid, c12-c14 alkyl benzoate, glyceryl distearate, blyceryl stearate se, behenyl alcohol, benzyl alcohol, cyclopentasiloxane, cyclohexasiloxane, stearic acid, lavandula angustifolia (lavender) oil, butylene glycol, carbomer, polysorbate 20, palmitoyl pentapeptide-4, beta-glucan, arginine, sodium stearoyl lactylate, triethanolamine, acrylate/c10-30 alkyl acrylate crosspolymer, potassium ascorbyl tocopheryl  phosphate, haematococcus pluvialis extract, carthamus tinctorius (safflower) seed oil, helianthus annus (sunflower) seed oil, tocopherol, tocotrienols, trilein, trilinolein, sodium lactate, potassium stearate, bht, mthyldibromo glutaronitrile, phenoxyethanol.

  • PRINCIPAL DISPLAY PANEL

    Outer Packaging

  • INGREDIENTS AND APPEARANCE
    HOPE IN A JAR FOR DRY SKIN SPF   BROAD SPECTRUM SPF 20 SUNSCREEN AND EXTRA-RICH MOISTURIZER FOR NORMAL TO DRY SKIN
    avobenzone, octinoxate, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-6400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone1.392 g  in 60 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate4.242 g  in 60 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone1.98 g  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DOCOSANOIC ACID (UNII: H390488X0A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
    1,3-BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CARBOMER 934 (UNII: Z135WT9208)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ARGININE (UNII: 94ZLA3W45F)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    SQUALENE (UNII: 7QWM220FJH)  
    RICE BRAN (UNII: R60QEP13IC)  
    METHYLDIBROMO GLUTARONITRILE (UNII: YX089CPS05)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50184-6400-21 in 1 BOX
    1NDC:50184-6400-160 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/22/2010
    Labeler - Philosophy, Inc. (948102256)
    Establishment
    NameAddressID/FEIBusiness Operations
    Philosophy Inc for BioTech Research Labs948102256manufacture(50184-6400)
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