FRESH SUGAR LIP TREATMENT SPF 15 (OCTINOXATE, OXYBENZONE) PASTE [FRESH INC.]

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  • FRESH SUGAR LIP TREATMENT SPF 15 (OCTINOXATE, OXYBENZONE) PASTE [FRESH INC.]

FRESH SUGAR LIP TREATMENT SPF 15 (OCTINOXATE, OXYBENZONE) PASTE [FRESH INC.]
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NDC 42406-016-00
Set ID 696cce52-ff59-417f-8c88-17cee8d5b349
Category HUMAN OTC DRUG LABEL
Packager Fresh Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts

  • Active Ingredients

    Octinoxate 7.49%
    Oxybenzone 2.00%

    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.

  • 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)

  • 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, Copernicia Cerifera (Carnauba) Wax, Sucrose Tetrastearate Triacetate, Triticum Vulgare (Wheat) Germ Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Persea Gratissima (Avocado) Oil, Ribes Nigrum (Black Currant) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Prunus Armeniaca (Apricot) Kernel Oil, Retinyl Palmitate, Ascorbyl Tetraisopalmitate, Ascorbyl Palmitate, Parfum (Fragrance), BHT, Tocopherol, Limonene, Citral, Benzyl Benzoate, Linalool, Benzyl Alcohol, Geraniol, Citronellol<05039/A>

  • Package Labeling:

    InnerDrugFactsBox

  • INGREDIENTS AND APPEARANCE
    FRESH SUGAR LIP TREATMENT SPF 15 
    octinoxate, oxybenzone paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42406-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.49 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    JOJOBA OIL (UNII: 724GKU717M)  
    HYDROGENATED OLIVE OIL DECYL ESTERS (UNII: XQ691JJ99N)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    RIBES NIGRUM SEED OIL (UNII: GKE1188837)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CITRAL (UNII: T7EU0O9VPP)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GERANIOL (UNII: L837108USY)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42406-016-001 in 1 BOX09/17/2015
    14.3 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/17/2015
    Labeler - Fresh Inc. (021403729)
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