Label: LIVESTS MOIST FOUNDATION 122- titanium dioxide liquid

  • 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 December 9, 2016

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Titanium dioxide 10.2%

  • 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.
    • higher SPF gives more sunburn protection.
    • provides moderate protection against sunburn and tanning.
  • 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 or irritation develops and lasts.

    • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

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

  • Directions

    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 value of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from10a.m.-2p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses.
    • Shake well before use.
    • Use a normal foundation.
    • Apply liberally and evenly 15 minutes before sun exposure.
    • Reapply as needed or after towel drying, swimming or perspiring.
    • Children under 6 months of age: ask a doctor.
  • Inactive ingredients

    water, cyclopentasiloxane, butylene glycol, Cl 77891, titanium dioxide, octyldodecyl neopentanoate, glycerin, talc, phenyl trimethicone, peg-9 olydimethylsiloxyethyl dimethicone, cetyl ethylhexanoate, neopentyl glycol diethylhexanoate, dimethicone, mica, Cl 77492, acrylates/dimethicone copolymer, aluminum hydroxide, betaine, polymethylsilsesquioxane, phytosteryl/isostearyl/cetyl/stearyl/behenyl dimer dilinoleate, dimethicone/vinyl dimethicone crosspolymer, stearic acid, sodium chloride, phenoxyethanol, Cl 77491, polyglyceryl-2 triisostearate, triethoxycaprylylsilane, Cl 77499, tocopherol, hydrogen dimethicone, hydroxyapatite, stearyl glycyrrhetinate, squalane, hydroxyproline, phytosteryl/octyldodecyl lauroyl glutamate, phytosteryl macadamlate, zinc oxide, palmitoyl proline, glycyrrhiza glabra (licorice) root extract, sodium palmitoyl sarcosinate, magnesium palmitoyl glutamate, palmitic acid, alumina, saxifraga sarmentosa extract, cynara scolymus (artichoke) leaf extract

  • Other Information

    • protect the product in this container from excessive heat and direct sun.
  • Principal Display Panel - 20 mL Carton Label

    LIVEST'S

    MOIST LIQUID FOUNDATION 122

    Liqud Foundation SUNSCREEN

    BROAD SPECTRUM

    SPF 15

    Warnings:

    The safety of this product has not been determined.

    NET 0.67 FL.OZ.

    (20 ML)

    Principal Display Panel - 20 mL Carton Label
  • INGREDIENTS AND APPEARANCE
    LIVESTS MOIST FOUNDATION 122 
    titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55655-270
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide2.31 g  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MICA (UNII: V8A1AW0880)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    BETAINE (UNII: 3SCV180C9W)  
    PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE (UNII: 8N725H4EFN)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
    HYDROXYPROLINE (UNII: RMB44WO89X)  
    STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    SQUALANE (UNII: GW89575KF9)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    PALMITOYL PROLINE (UNII: I49727TDYF)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    SODIUM PALMITOYL SARCOSINATE (UNII: 7297LY09YF)  
    MAGNESIUM PALMITOYL GLUTAMATE (UNII: DH37YM1F48)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)  
    CYNARA SCOLYMUS LEAF (UNII: B71UA545DE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55655-270-011 in 1 BOX12/09/2016
    120 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/09/2016
    Labeler - ARSOA HONSHA CORPORATION (694245452)
    Establishment
    NameAddressID/FEIBusiness Operations
    NIPPON SHIKIZAI, INC694869178ANALYSIS(55655-270) , LABEL(55655-270) , MANUFACTURE(55655-270) , PACK(55655-270) , PARTICLE SIZE REDUCTION(55655-270) , RELABEL(55655-270) , REPACK(55655-270) , STERILIZE(55655-270)