Label: LAURA GELLER BEAUTY SUN KISSED COLOR LIP BALM TRIO BROAD SPECTRUM SPF 15 PINK - CORAL - BERRY- octisalate, avobenzone, octinoxate, octocrylene kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 26, 2019

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  • LAURA GELLER BEAUTY SUN KISSED COLOR LIP BALM TRIO BROAD SPECTRUM SPF 15 Pink - Coral - Berry


  • Active Ingredients

    Octisalate 5%
    Avobenzone 2.5%
    Octinoxate 2%
    Octocrylene 1.5%

    Purpose

    Sunscreen

  • WARNINGS

    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

    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses.
    • children under 6 months of age: Ask a doctor.
  • Inactive Ingredients

    Berry: Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Polyethylene, Pentaerythrityl Tetraisostearate, Mica, Microcrystalline Wax, Helianthus Annuus (Sunflower) Seed Wax, Silica Silylate, Stearalkonium Bentonite, Dicalcium Phosphate, Tocopheryl Acetate, Propylene Carbonate, Ethyl Vanillin, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, 1,2-Hexanediol, Caprylyl Glycol, Mangifera Indica (Mango) Seed Butter, Ethylhexyl Cocoate, Cocos Nucifera (Coconut) Oil. May Contain: Titanium Dioxide, Red 7 Lake, Iron Oxides, Blue 1 Lake Coral, Pink: Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Polyethylene, Pentaerythrityl Tetraisostearate, Mica, Microcrystalline Wax, Helianthus Annuus (Sunflower) Seed Wax, Dicalcium Phosphate, Silica Silylate, Stearalkonium Bentonite,
    Tocopheryl Acetate, Propylene Carbonate, Ethyl Vanillin, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, 1,2-Hexanediol, Caprylyl Glycol, Mangifera Indica (Mango) Seed Butter, Ethylhexyl Cocoate, Cocos Nucifera (Coconut) Oil. May Contain: Titanium Dioxide, Red 28 Lake, Red 6

  • Other Information

    • Protect the product in this container from excessive heat and direct sun.
  • Questions or comments?

    Call Laura Geller Beauty, LLC, 1 (800) MAKE UP4

  • LAURA GELLER BEAUTY SUN KISSED COLOR LIP BALM TRIO BROAD SPECTRUM SPF 15 Pink - Coral - Berry (51389-122-03)

    LAURA GELLER Sun Kissed Lip Balm broad spectrum SPF 15 PINK 2.5g (51389-123-01)

    LAURA GELLER Sun Kissed Lip Balm broad spectrum SPF 15 CORAL 2.5g (51389-124-01)

    LAURA GELLER Sun Kissed Lip Balm broad spectrum SPF 15 BERRY 2.5g (51389-125-01)

    PINK LabelCORAL LabelBERRY LabelTube LabelOuter Package

  • INGREDIENTS AND APPEARANCE
    LAURA GELLER BEAUTY SUN KISSED COLOR LIP BALM TRIO BROAD SPECTRUM SPF 15 PINK - CORAL - BERRY 
    octisalate, avobenzone, octinoxate, octocrylene kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51389-122
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51389-122-031 in 1 KIT; Type 1: Convenience Kit of Co-Package12/09/2013
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 2.5 g
    Part 21 TUBE 2.5 g
    Part 31 TUBE 2.5 g
    Part 1 of 3
    LAURA GELLER SUN KISSED LIP BALM BROAD SPECTRUM SPF 15 PINK 
    octisalate, avobenzone, octinoxate, octocrylene lipstick
    Product Information
    Item Code (Source)NDC:51389-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    ETHYLHEXYL COCOATE (UNII: I1MPW273QS)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51389-123-011 in 1 PACKAGE
    12.5 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 finalpart35212/06/2013
    Part 2 of 3
    LAURA GELLER SUN KISSED LIP BALM BROAD SPECTRUM SPF 15 CORAL  
    octisalate, avobenzone, octinoxate, octocrylene lipstick
    Product Information
    Item Code (Source)NDC:51389-124
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    ETHYLHEXYL COCOATE (UNII: I1MPW273QS)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51389-124-011 in 1 PACKAGE
    12.5 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 finalpart35212/06/2013
    Part 3 of 3
    LAURA GELLER SUN KISSED LIP BALM BROAD SPECTRUM SPF 15 BERRY  
    octisalate, avobenzone, octinoxate, octocrylene lipstick
    Product Information
    Item Code (Source)NDC:51389-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    ETHYLHEXYL COCOATE (UNII: I1MPW273QS)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51389-125-011 in 1 PACKAGE
    12.5 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 finalpart35212/06/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/09/2013
    Labeler - LAURA GELLER MAKE UP INC. (199474524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gotha Cosmetics SRL378071679manufacture(51389-125, 51389-124, 51389-123, 51389-122)
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