YOUTH CELL DAY BROAD SPECTRUM SPF-15 SUNSCREEN (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENE) CREAM [ILUMINAGE BEAUTY, INC.]

YOUTH CELL DAY BROAD SPECTRUM SPF-15 SUNSCREEN (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENE) CREAM [ILUMINAGE BEAUTY, INC.]
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NDC 69047-001-03, 69047-001-04
Set ID 89370caf-4805-4468-acc7-95f7f8912df1
Category HUMAN OTC DRUG LABEL
Packager Iluminage Beauty, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Avobenzone 3%

    Octinoxate 6%

    Octisalate 3%

    Octocrylene 2.4%

  • 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

    • apply liberally 15 minutes before sun exposure
    • reapply at least every two hours
    • use a water resistant sunscreen if swimming or sweating
    • children under 6 months of age: ask a doctor

    • 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 from 10 a.m.–2 p.m.  

         - wear long-sleeved shirts, pants, hats and sunglasses                                

  • Inactive ingredients

    Water/Aqua, Cyclopentasiloxane, Nia-

    cinamide, Glycerin, Cetearyl Alcohol,

    Dimethicone, PEG-100 Stearate, Poly-

    Methylsilsesquixane, Isomerized Linoleic

    Acid, Tocopheryl Acetate, Cholesterol,

    Stearic Acid, Caprylic/Capric Triglyceride,

    Pentapeptide-31, Ammonium

    Acryloydimethyltaurate/Beheneth-25

    Methylacrylate Crosspolymer, Tocopherol,

    Behenyl Alcoho, Palmitic Acid, Linoleic

    Acid, Oleic Acid, Ceteareth-20, Butylene

    Glycol, Cetyl Alcohol, Stearyl Alcohol,

    Arachidyl Alcohol, Ammonium Lactate,

    Pentaerythiryl Tetra-di-t-butyl Hydro-

    Xyhydrocinnamate, Isohexadecane, Poly-

    Methyl Methacrylate, Sodium Polyacry-

    Loyldimethyl Taurate, Ethylene/Arcylic

    Acid Copolymer, Poloxamer 338, Silica,

    Hydrogenated Polydecene, Trideceth-10,

    Dimethiconol, Calcium Aluminum

    Borosilicate, Methylisothiszolinone, Cap-

    prylyl Glycol, Fragrance, Acetamide MEA,

    Polyglycerin-3, BHT, Phenoxyethanol,

    Propylene Glycol, Sodium Benzoate,

    Citric Acid, Disodium EDTA, Limonene,

    Linalool, tin Oxide. Titanium Dioxide

    (CI 77891).

  • Other information

    protect the product in this container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL

    Label

    3 mL packette

  • INGREDIENTS AND APPEARANCE
    YOUTH CELL DAY  BROAD SPECTRUM SPF-15 SUNSCREEN
    avobenzone, octinoxate, octisalate, and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69047-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 mg  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 mg  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.4 mg  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETAMIDE (UNII: 8XOE1JSO29)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)  
    AMMONIUM LACTATE (UNII: 67M901L9NQ)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MICA (UNII: V8A1AW0880)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLOXAMER 338 (UNII: F75JV2T505)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIDECETH-10 (UNII: G624N6MSBA)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69047-001-041 in 1 CARTON10/16/2013
    1NDC:69047-001-033 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/16/2013
    Labeler - Iluminage Beauty, Inc. (032551374)

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