FRESH SUGAR TULIP TINTED LIP TREATMENT SUNSCREEN SPF 15 (AVOBENZONE, OCTINOXATE) STICK [FRESH, INC.]

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  • FRESH SUGAR TULIP TINTED LIP TREATMENT SUNSCREEN SPF 15 (AVOBENZONE, OCTINOXATE) STICK [FRESH, INC.]

FRESH SUGAR TULIP TINTED LIP TREATMENT SUNSCREEN SPF 15 (AVOBENZONE, OCTINOXATE) STICK [FRESH, INC.]
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NDC 42406-006-00
Set ID 469f9cc4-a6f5-4c18-831b-30c7b9e05a3e
Category HUMAN OTC DRUG LABEL
Packager Fresh, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Fresh Sugar Tulip Tinted Lip Treatment Sunscreen SPF 15


  • Active Ingredients

    Avobenzone 2.00%
    Octinoxate 7.49%

    Purpose

    Sunscreen

  • Use

    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.

  • Inactive Ingredients

    Cera Alba (Beeswax), Ricinus Communis (Castor) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Hydrogenated Olive Oil Decyl Esters, Vitis Vinifera (Grape) Seed Oil, Parfum (Fragrance), Copernicia Cerifera (Carnauba) Wax, Persea Gratissima (Avocado) Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Passiflora Incarnata Seed Oil, Sucrose Tetrastearate Triacetate, Ribes Nigrum (Black Currant) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Retinyl Palmitate, Ascorbyl Tetraisopalmitate, Tocopherol, Ascorbyl Palmitate, CI 15850 (Red 7 Lake), CI 19140 (Yellow 5 Lake), CI 15850 (Red 6), CI 77491 (Iron Oxides), Ammonium Glycyrrhizate, CI 77891 (Titanium Dioxide), Polyglyceryl-3 Polyricinoleate, Vanillin, BHT, Propyl Gallate, Aluminum Hydroxide, CI 42090 (Blue 1 Lake), Limonene, Citral, Benzyl Alcohol, Linalool, Geraniol (07624/Z)

  • Directions

    For sunscreen use:

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

    Protect this product in container from excessive heat and direct sun

  • Questions or Comments?

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

  • Fresh Sugar Tulip Tinted Lip Treatment Sunscreen SPF 15 4.3g (42406-006-00)

    123

  • INGREDIENTS AND APPEARANCE
    FRESH SUGAR TULIP TINTED LIP TREATMENT SUNSCREEN SPF 15 
    avobenzone, octinoxate stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42406-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.49 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    PASSIFLORA INCARNATA SEED OIL (UNII: S0SU5AC95J)  
    SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)  
    RIBES NIGRUM SEED OIL (UNII: GKE1188837)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    VANILLIN (UNII: CHI530446X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CITRAL (UNII: T7EU0O9VPP)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GERANIOL (UNII: L837108USY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42406-006-001 in 1 CARTON01/09/2014
    14.3 g in 1 TUBE; 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
    Parfums Christian Dior396393746manufacture(42406-006)
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