Label: ALL AGLOW PERFECT CUSHION FOUNDATION- titanium dioxide,octyl methoxycinnamate,octyl salicylate,octocrylene,zinc oxide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 25, 2016

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

  • ACTIVE INGREDIENT

    Titanium Dioxide 9%

    Octyl methoxycinnamate 7%

    Octyl Salicylate 4.8%

    Octocrylene 2%

    Zinc Oxide 2%

  • INDICATIONS & USAGE

    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.
    – Keep out of eyes. Rinse with water to remove.
    – Stop use if a rash develops. Consult a physician.
    .

  • Directions


    Apply liberally 15 minutes before sun exposure.
    Reapply at least every 2 hours.

  • Other information

    • Protect the product in this container from excessive heat and sun.
  • Inactive ingredients

    WATER, CYCLOPENTASILOXANE (CYCLOMETHICONE), DIPHENYLSILOXY
    PHENYL TRIMETHICONE, CYCLOHEXASILOXANE (CYCLOMETHICONE),
    C12-15 ALKYL BENZOATE, NIACINAMIDE, CAPRYLYL METHICONE,
    TRIMETHYLSILOXYSILICATE, PEG-30 DIPOLYHYDROXYSTEARATE,
    PEG-10 DIMETHICONE, BUTYLENE GLYCOL, VINYL
    DIMETHICONE/METHICONE SILSESQUIOXANE CRTOSSPOLYMER,
    SODIUM CHLORIDE, QUATERNIUM-18 BENTONITE,
    ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE
    COPOLYMER, POLYMETHYL METHACRYLATE, IRON OXIDE,
    DIMETHICONE, ACRYLATES/DIMETHICONE COPOLYMER, BORON
    NITRIDE, CHLORPHENESIN, TRIETHOXYCAPRYLYLSILANE,
    ALUMINA (CI 77002), CITRUS MEDICA LIMONUM (LEMON) PEEL
    OIL, ADENOSINE, HONEY, LAVANDULA ANGUSTIFOLIA (LAVENDER)
    OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL,
    EUCALYPTUS GLOBULUS LEAF OIL, CITRUS AURANTIUM DULCIS
    (ORANGE) PEEL OIL, CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL,
    HYDROGENATED LECITHIN, 1,2-HEXANEDIOL, CHOLESTEROL,
    PEG-800, GLYCERIN, POLYSORBATE 20, SH-OLIGOPEPTIDE-1,
    SH-POLYPEPTIDE-1, SH-POLYPEPTIDE-8, SH-POLYPEPTIDE-9,
    SH-POLYPEPTIDE-45, SH-OLIGOPEPTIDE-2, SH-POLYPEPTIDE-22.

  • PURPOSE

    PURPOSE

    SUNSCREEN

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If product is swallowed, get medical help or contact a poison control center right away

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ALL AGLOW PERFECT CUSHION  FOUNDATION
    titanium dioxide,octyl methoxycinnamate,octyl salicylate,octocrylene,zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58544-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 mg  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2 mg  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.8 mg  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mg  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PEG-80 STEARATE (UNII: 1X2OAT3BFK)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    CITRUS MEDICA FRUIT (UNII: ZE5Q6PN9ON)  
    ALUMINUM HYDROXIDE SULFATE (AL(OH)(SO4)) (UNII: 9QO62ZS7VO)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENTOQUATAM (UNII: 7F465U79Q1)  
    STEARYL CAPRYLATE (UNII: 06TS6O9194)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    HONEY (UNII: Y9H1V576FH)  
    JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)  
    ADENOSINE (UNII: K72T3FS567)  
    NEPIDERMIN (UNII: TZK30RF92W)  
    BASIC FIBROBLAST GROWTH FACTOR (HUMAN) (UNII: S3529G9M9V)  
    MECASERMIN (UNII: 7GR9I2683O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58544-001-0115 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/25/2016
    Labeler - Hankook Cosmetics Manufacturing Co., Ltd._eumseong Factory (687772475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hankook Cosmetics Manufacturing Co., Ltd._eumseong Factory688235645manufacture(58544-001)