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

FRESH SUGAR CORAL TINTED LIP TREATMENT SPF 15 (OCTINOXATE, AVOBENZONE) STICK [FRESH, INC.]
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NDC 42406-002-00
Set ID 93798d90-4dbb-4c9e-9bb0-dc90b85fbe23
Category HUMAN OTC DRUG LABEL
Packager Fresh, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENTS:

    Octinoxate (Ethylhexyl Methoxycinnamate) 7.49 %
    Avobenzone (Butyl Methoxydibenzoylmethane) 2.00 %

  • OTHER 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 77492 (Iron Oxides), CI 77891 (Titanium Dioxide), CI 15890 (Red 7 Lake), CI 15850 (Red 6), Ammonium Glycyrrhizate, Polyglyceryl-3 Polyricinoleate, Vanillin, BHT, CI 77499 (Iron Oxides), Propyl Gallate, Limonene, Citral, Benzyl Alcohol, Linalool

  • Warning:

    Avoid contact with the eyes. For external use only.

  • Keep out of reach of children

    Keep out of reach of children

  • Stop Use

    Discontinue use if signs of irritation or rash appear.

  • To Use:

    Apply prior to sun exposure

  • Purpose

    Sunscreen

  • Description

    SPF 15  Fresh® Sugar Coral Tinted Lip Treatment SPF 15 moisturizes, protects, and smoothes the lips while leaving a juicy coral tint, offering sheer coverage or buildable color. It is the perfect partner to our popular Sugar Lip Treatment SPF 15.  H00002484  Fresh Inc NYC 10022 USA London W1U4RD UK www.fresh.com Made in France ©2011

  • PRINCIPAL DISPLAY PANEL

    fresh F21C  Active Ingredients  Octinoxate : 7.49%  Avobenzone : 2%

  • PRINCIPAL DISPLAY PANEL

    TO USE  Apply prior to sun exposure  WARNING  Avoid contact with the eyes. For external use only. Keep out of reach of children. Discontinue use if signs of irritation or rash appear.

  • PRINCIPAL DISPLAY PANEL

    SUGAR CORAL fresh F21C  SUGAR CORAL TINTED LIP TREATMENT  SPF 15 4.3g e 0.15oz  Fresh Inc NYC 10022 USA London W1U4RD UK  www.fresh.com Made in France ©2011  Important: See Leaflet / Voir Notice

  • PRINCIPAL DISPLAY PANEL

    fresh SUGAR CORAL LIP TREATMENT 4.3g e 0.15oz fresh F21C

  • Fresh Sugar Coral Tinted Lip Treatment SPF 15 4.3g (42406-002-00)

    Fresh Sugar Coral Tinted Bottom Label

  • PRINCIPAL DISPLAY PANEL

    Fresh Sugar Coral Tinted Warning

  • PRINCIPAL DISPLAY PANEL

    Fresh Sugar Coral Tinted Outer Package

  • PRINCIPAL DISPLAY PANEL

    Coral Box Label

  • INGREDIENTS AND APPEARANCE
    FRESH SUGAR CORAL TINTED LIP TREATMENT SPF 15 
    octinoxate, avobenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42406-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.49 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    VANILLIN (UNII: CHI530446X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    CITRAL (UNII: T7EU0O9VPP)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    PASSIFLORA INCARNATA SEED OIL (UNII: S0SU5AC95J)  
    RIBES NIGRUM SEED OIL (UNII: GKE1188837)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42406-002-001 in 1 CARTON02/08/2012
    14.3 g in 1 BOX; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/08/2012
    Labeler - Fresh, Inc. (021403729)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guerlain S.A266623064manufacture(42406-002)

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