Label: HOPE IN A JAR A TO Z CREAM BROAD SPECTRUM SPF 20 SUNSCREEN- titanium dioxide, zinc oxide cream

  • NDC Code(s): 50184-1033-1, 50184-1033-2
  • Packager: Philosophy
  • 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 January 24, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Titanium Dioxide (5.0%)

    Zinc Oxide (5.0%)

  • 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.

    Do not use on damaged or broken skin.

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children.

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

  • Directions

    • pump to dispense product, layer for more coverage
    • 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 – this product should NOT be used on children of any age
  • Inactive Ingredients

    aqua/water/eau, cyclopentasiloxane, octyldodecyl neopentanoate, butylene glycol, glycerin, peg/ppg-18/18 dimethicone, dimethicone, camellia oleifera leaf extract, aluminum hydroxide, stearic acid, boron nitride, lactic acid, sodium chloride, caprylyl glycol, sodium dehydroacetate, mica, phytantriol, triethoxycaprylylsilane, dextrin palmitate, sodium hyaluronate, lysine, retinyl acetate, tetrahexyldecyl ascorbate, tocopherol, avena sativa (oat) bran extract, magnesium ascorbyl phosphate, magnesium chloride, potassium chloride, retinyl palmitate, potassium sorbate, hexylene glycol, disodium edta, palmitic acid, sodium benzoate, zinc chloride, phenoxyethanol, may contain: titanium dioxide (ci 77891), zinc oxide (ci 77947), iron oxides (ci 77491, ci 77492, ci 77499).

  • 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)

  • Principal Display Panel – 30mL Box Label

    philosophy

    hope
    in a jar

    a to z cream

    broad spectrum

    spf 20 sunscreen

    complexion perfecting

    bb cream

    30ml/1 fl. oz.

    Principal Display Panel – 30mL Box Label
  • INGREDIENTS AND APPEARANCE
    HOPE IN A JAR   A TO Z CREAM BROAD SPECTRUM SPF 20 SUNSCREEN
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-1033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.35 g  in 30 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION5.49 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    MICA (UNII: V8A1AW0880)  
    PHYTANTRIOL (UNII: 8LVI07A72W)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    LYSINE (UNII: K3Z4F929H6)  
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    OAT BRAN (UNII: KQX236OK4U)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50184-1033-21 in 1 BOX05/01/2013
    1NDC:50184-1033-130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2013
    Labeler - Philosophy (948102256)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mana Products, INC032870270manufacture(50184-1033)
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