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

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FRESH SUGAR ROSE TINTED LIP TREATMENT SPF 15 (OCTINOXATE, OXYBENZONE) PASTE [FRESH INC.]
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NDC 42406-013-00
Set ID 441e871c-e07f-4e99-92a9-fcf72e63ee86
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, Parfum (Fragrance), Copernicia Cerifera (Carnauba) Wax, Persea Gratissima (Avocado) Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Ribes Nigrum (Black Currant) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Rosa Damascena Flower Water, Retinyl Palmitate, Ascorbyl Palmitate, Ascorbyl Tetraisopalmitate, Tocopherol, Sucrose Tetrastearate Triacetate, CI 15985 (Yellow 6 Lake), CI 77891 (Titanium Dioxide), CI 15850 (Red 7 Lake), Polyglyceryl-3 Polyricinoleate, CI 77491 (Iron Oxides), CI 77499 (Iron Oxides), Propyl Gallate, Limonene, Benzyl Alcohol, Linalool, BHT, Citral, Citronellol, Geraniol <04717/A>

  • Package Labeling:

    InnerDrugFactsCapBox

  • INGREDIENTS AND APPEARANCE
    FRESH SUGAR ROSE TINTED LIP TREATMENT SPF 15 
    octinoxate, oxybenzone paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42406-013
    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)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    RIBES NIGRUM SEED OIL (UNII: GKE1188837)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CITRAL (UNII: T7EU0O9VPP)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    GERANIOL (UNII: L837108USY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42406-013-001 in 1 BOX09/18/2015
    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 finalpart35209/18/2015
    Labeler - Fresh Inc. (021403729)
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