ULTIMATE MIRACLE WORKER EYE SPF 15 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE) CREAM [PHILOSOPHY, INC.]

ULTIMATE MIRACLE WORKER EYE SPF 15 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE) CREAM [PHILOSOPHY, INC.]
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NDC 50184-1012-1
Set ID aafae6da-5343-4442-8de3-ae65c4079c1e
Category HUMAN OTC DRUG LABEL
Packager Philosophy, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Avobenzone 2.7%

    Homosalate 2%

    Octinoxate 5%

    Octocrylene 2.16%

  • 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

    • use in the morning. apply gently under eyes, extending toward the temple
    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water-resistant sunscreen if swimming or sweating
    • 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 from 10 a.m. – 2 p.m.
      • wear long-sleeved shirts, pants, hats and sunglasses
    • children under 6 months: ask a doctor
  • Inactive Ingredients

    water, glycerin, dicaprylyl carbonate, isononyl isononanoate, methyl methacrylate crosspolymer, dimethicone, cyclopentasiloxane, tribehenin peg-20 esters, cetyl alcohol, isostearyl isostearate, trisiloxane, glyceryl stearate, peg-100 stearate, cetyl stearate, stearic acid, bifida ferment lysate, potassium cetyl phosphate, phenoxyethanol, dimethicone crosspolymer, caffeine, chlorphenesin, propylene glycol, carbomer, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, glycine soja (soybean) oil, sodium hydroxide, squalane, hippophae rhamnoides oil, iris pallida root extract, ruby powder, disodium edta, alcohol, algae extract, mica, lecithin, ascorbyl glucoside, adenosine, cellulose gum, ginkgo biloba leaf extract, retinol, peg-8, polysorbate 20, polysorbate 60, calcium sodium phos-phosilicate, bht, acrylates/c10-30 alkyl acrylate crosspolymer, chitosan, ethylhexylglycerin, glycolic acid, sorbitan oleate, tocopherol, aesculus hippocastanum (horse chestnut) seed extract, glucose, lactic acid, behentrimonium chloride, glycyrrhiza uralensis (licorice) root extract, sodium benzoate, ascorbyl palmitate, potassium phosphate, potassium sorbate, camellia sinensis leaf extract, coffea arabica (coffee) seed extract, pongamia pinnata seed extract, isopropyl alcohol, acetic acid, angelica archangelica root extract, citrus aurantium amara (bitter orange) peel extract, maltodextrin, citric acid, magnesium aluminum silicate, xanthan gum, ascorbic acid, glycyrrhiza glabra (licorice) rhizome/root extract, glycyrrhiza glabra (licorice) root extract, caprylyl glycol, sclerotium gum, bha, sorbic acid, titanium dioxide (ci 77891).

  • Other Information

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

    Call toll-free 1-800-568-3151 from 9 a.m. - 8 p.m. EST (Monday – Friday)

  • Principal Display Panel - Ultimate Miracle Worker Eye Carton Label

    ultimate
    miracle
    worker eye

    philosophy: the best is yet to come.

    multi-rejuvenating eye cream
    broad spectrum spf 15 sunscreen

    wrinkles, firmness, dark circles, puffiness

    philosophy

    15 ml/0.5 fl. oz.

    Principal Display Panel - Ultimate Miracle Worker Eye Carton Label
  • INGREDIENTS AND APPEARANCE
    ULTIMATE MIRACLE WORKER EYE SPF 15 
    avobenzone, homosalate, octinoxate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-1012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.7 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.16 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETYL STEARATE (UNII: 06RI5UQA7L)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    CAFFEINE (UNII: 3G6A5W338E)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SQUALANE (UNII: GW89575KF9)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ALCOHOL (UNII: 3K9958V90M)  
    MICA (UNII: V8A1AW0880)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    ADENOSINE (UNII: K72T3FS567)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    GINKGO (UNII: 19FUJ2C58T)  
    RETINOL (UNII: G2SH0XKK91)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    POLIGLUSAM (UNII: 82LKS4QV2Y)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    GLYCYRRHIZA URALENSIS (UNII: 42B5YD8F0K)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ARABICA COFFEE BEAN (UNII: 3SW678MX72)  
    MILLETTIA PINNATA SEED (UNII: C2BRV53B1V)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    CITRUS AURANTIUM FRUIT RIND (UNII: 055456JHI7)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    SORBIC ACID (UNII: X045WJ989B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50184-1012-11 in 1 CARTON04/01/2018
    115 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2018
    Labeler - Philosophy, Inc. (948102256)
    Establishment
    NameAddressID/FEIBusiness Operations
    Process Technologies and Packaging Inc.809172885manufacture(50184-1012)

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