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
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NDC Code(s):
81104-603-01,
81104-603-02,
81104-604-01,
81104-604-02, view more81104-605-01, 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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
- PURPOSE
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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
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INGREDIENTS AND APPEARANCE
POUTSCREEN LIP TREATMENT TIRAMISU
avobenzone, octinoxate, octocrylene liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81104-605 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:81104-605-02 1 in 1 CARTON 07/08/2026 1 NDC:81104-605-01 15 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/08/2026 POUTSCREEN LIP TREATMENT CHOCOLATE KISS
avobenzone, octinoxate, octocrylene liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81104-604 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:81104-604-02 1 in 1 CARTON 07/08/2026 1 NDC:81104-604-01 15 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/08/2026 POUTSCREEN LIP TREATMENT LEMON MERINGUE
avobenzone, octinoxate, octocrylene liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81104-603 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:81104-603-02 1 in 1 CARTON 06/04/2026 1 NDC:81104-603-01 15 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/04/2026 Labeler - NAKED SUNDAYS PTY LTD (746918845)



