FRESH PEONY BRIGHTENING UV SHIELD SUNSCREEN SPF 50 PLUS (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [FRESH, INC.]

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  • FRESH PEONY BRIGHTENING UV SHIELD SUNSCREEN SPF 50 PLUS (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [FRESH, INC.]

FRESH PEONY BRIGHTENING UV SHIELD SUNSCREEN SPF 50 PLUS (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [FRESH, INC.]
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NDC 42406-007-00
Set ID 5feb6af0-bfc7-48da-8248-59b8b87085bc
Category HUMAN OTC DRUG LABEL
Packager Fresh, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Fresh Peony Brightening UV Shield Sunscreen SPF 50+


  • Active Ingredients

    Octinoxate 7.49%
    Oxybenzone 2.00%
    Titanium Dioxide 8.88%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
    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 product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For sunscreen use:

    • Apply liberally 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • Children under 6 months: Ask a doctor
  • Other Information

    Protect this product in container from excessive heat and direct sun

  • Inactive Ingredients

    Aqua (water), C12-15 Alkyl Benzoate, Phenyl Trimethicone, Butylene Glycol, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, CI 77891 (Titanium Dioxide), Isododecane, Diphenylsiloxy Phenyl Trimethicone, Silica, Vinyl Dimethicone/Methicone Silsesqulaxene Crosspolymer, Ascorbyl Glucoside, Aluminum Stearate, Polyhydroxystearic Acid, Magnesium Sulfate, Citrus Limon (Lemon) Peel Oil, Butyrospermum Parkii (Shea) Seedcake Extract, Cucumis Sativus (Cucumber) Fruit Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Paeonia Suffruticosa Root Extract, Sodium Hyaluronate, Tocopheryl Acetate, Tocopherol, Tromethamine, Mica, Alumina, Sorbitan Sesquioleate, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Sodium Citrate, Disteardimonium Hectorite, Caprylyl Glycol, Tetrasodium EDTA, Caprylic/Capric Triglyceride, Sodium Myristoyl Glutamate, Propylene Carbonate, Stearyl Glycyrrhetinate, CI 77492 (Iron Oxides), CI 77491 (Iron Oxides), Aluminum Hydroxide, Citric Acid, BHT, CI 77499 (Iron Oxides), Phenoxyethanol, Limonene, Citral (08302/Z). 12M

  • Questions or Comments?

    Call toll free 1(800)FRESH-20 Monday-Friday (9 a.m. to 5p.m EST)

  • Fresh Peony Brightening UV Shield Sunscreen SPF 50+ 30ml (42406-007-00)

    Peony Inner LabelPeony Outer Label

  • INGREDIENTS AND APPEARANCE
    FRESH PEONY BRIGHTENING UV SHIELD SUNSCREEN SPF 50 PLUS 
    octinoxate, oxybenzone, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42406-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE74.9 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE88.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISODODECANE (UNII: A8289P68Y2)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    LEMON OIL (UNII: I9GRO824LL)  
    CUCUMBER (UNII: YY7C30VXJT)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    MICA (UNII: V8A1AW0880)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CITRAL (UNII: T7EU0O9VPP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42406-007-001 in 1 CARTON01/09/2014
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/09/2014
    Labeler - Fresh, Inc. (021403729)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guerlain S.A.266623064manufacture(42406-007)
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