Label: POUTSCREEN LIP TREATMENT TIRAMISU- avobenzone, octinoxate, octocrylene liquid
POUTSCREEN LIP TREATMENT CHOCOLATE KISS- avobenzone, octinoxate, octocrylene liquid
POUTSCREEN LIP TREATMENT LEMON MERINGUE- avobenzone, octinoxate, octocrylene liquid

  • NDC Code(s): 81104-603-01, 81104-603-02, 81104-604-01, 81104-604-02, view more
    81104-605-01, 81104-605-02
  • Packager: NAKED SUNDAYS PTY LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 10, 2026

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE

    Use: • Helps prevent sunburn. • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun

  • WARNINGS

    Warnings: For external use only.

    • Do not use on damaged or broken skin.

  • WHEN USING

    When using this product: Keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor: If rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: If product is swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions:

    • Apply liberally and evenly 15 minutes before sun exposure.

    • Re-apply at least every 80 minutes or immediately after swimming, sweating or towel drying.

    • Use a water-resistant sunscreen if swimming or sweating.

    Children under 6 months of age: Ask a doctor

    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 10.00AM - 2.00PM

    • Wear long-sleeved shirts, pants, hats, and sunglasses

  • OTHER SAFETY INFORMATION

    Other Information:

    • Protect this product from excess heat and direct sun.

    • Store below 30°C / 86°F

    Questions:

    • info@nakedSundays.com

  • PURPOSE

    Sunscreen

  • INACTIVE INGREDIENT

    Trimasu:

    Water, Polybutene (1400 MW), Isopropyl Myristate, Caprylic/Capric Triglyceride, Octyldodecanol, Squalane, Cocos Nucifera (Coconut) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Pentaerythrityl Tetraisostearate, Ethylhexyl Methoxycrylene, Sorbitan Oleate, Stearalkonium Hectorite, Propylene Carbonate, Silica Dimethyl Silylate, Behenyl Acrylate Polymer, Polyglutamic Acid (1200 MW), Palmitoyl Hexapeptide-12, Solanum Lycopersicum (Tomato) Fruit Extract, Sucralose, Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77499), Yellow 5 (CI 19140).

    Chocolate Kiss:

    Isopropyl Myristate, Cocos Nucifera (Coconut) Oil, Stearalkonium Hectorite, Palmitoyl Hexapeptide-12, Mica, Solanum Lycopersicum (Tomato) Fruit Extract, Polyglutamic Acid, Sucralose, Water, Silica Dimethyl Silylate, Polybutene, Ethylhexyl Methoxycrylene, Sorbitan Oleate, CI 77891, Squalane, Propylene Carbonate, Pentaerythrityl Tetraisostearate, Octyldodecanol, Behenyl Acrylate Polymer, Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Seed Oil, CI 77491, CI 19140, CI 77499.

    Lemon Meringue:

    Isopropyl Myristate, Cocos Nucifera (Coconut) Oil, Stearalkonium Hectorite, Palmitoyl Hexapeptide-12, Mica, Solanum Lycopersicum (Tomato) Fruit Extract, Polyglutamic Acid, Sucralose, Water, Silica Dimethyl Silylate, Polybutene, Ethylhexyl Methoxycrylene, Sorbitan Oleate, CI 77891, Squalane, Propylene Carbonate, Pentaerythrityl Tetraisostearate, Octyldodecanol, Behenyl Acrylate Polymer, Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Seed Oil, CI 77491.

  • PRINCIPAL DISPLAY PANEL

    lnv

  • INGREDIENTS AND APPEARANCE
    POUTSCREEN LIP TREATMENT TIRAMISU 
    avobenzone, octinoxate, octocrylene liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81104-605
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
    MICA (UNII: V8A1AW0880)  
    SOLANUM LYCOPERSICUM (TOMATO) FRUIT (UNII: Z4KHF2C175)  
    POLYGLUTAMIC ACID (1200 MW) (UNII: MGE3733FR2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    SORBITAN OLEATE (UNII: 06XEA2VD56)  
    CI 77891 (UNII: 15FIX9V2JP)  
    SQUALANE (UNII: GW89575KF9)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)  
    CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
    SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)  
    CI 77491 (UNII: 1K09F3G675)  
    CI 19140 (UNII: I753WB2F1M)  
    CI 77499 (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81104-605-021 in 1 CARTON07/08/2026
    1NDC:81104-605-0115 mL 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 DrugM02007/08/2026
    POUTSCREEN LIP TREATMENT CHOCOLATE KISS 
    avobenzone, octinoxate, octocrylene liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81104-604
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
    MICA (UNII: V8A1AW0880)  
    SOLANUM LYCOPERSICUM (TOMATO) FRUIT (UNII: Z4KHF2C175)  
    POLYGLUTAMIC ACID (1200 MW) (UNII: MGE3733FR2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    SORBITAN OLEATE (UNII: 06XEA2VD56)  
    CI 77891 (UNII: 15FIX9V2JP)  
    SQUALANE (UNII: GW89575KF9)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)  
    CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
    SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)  
    CI 77491 (UNII: 1K09F3G675)  
    CI 19140 (UNII: I753WB2F1M)  
    CI 77499 (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81104-604-021 in 1 CARTON07/08/2026
    1NDC:81104-604-0115 mL 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 DrugM02007/08/2026
    POUTSCREEN LIP TREATMENT LEMON MERINGUE 
    avobenzone, octinoxate, octocrylene liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81104-603
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
    MICA (UNII: V8A1AW0880)  
    SOLANUM LYCOPERSICUM (TOMATO) FRUIT (UNII: Z4KHF2C175)  
    POLYGLUTAMIC ACID (1200 MW) (UNII: MGE3733FR2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    SORBITAN OLEATE (UNII: 06XEA2VD56)  
    CI 77891 (UNII: 15FIX9V2JP)  
    SQUALANE (UNII: GW89575KF9)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)  
    CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
    SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)  
    CI 77491 (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81104-603-021 in 1 CARTON06/04/2026
    1NDC:81104-603-0115 mL 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 DrugM02006/04/2026
    Labeler - NAKED SUNDAYS PTY LTD (746918845)