POUTSCREEN LIP TREATMENT MIDNIGHT KISS- avobenzone, octinoxate, octocrylene liquid POUTSCREEN LIP TREATMENT LOVE LETTER- avobenzone, octinoxate, octocrylene liquid POUTSCREEN LIP TREATMENT DARLING- avobenzone, octinoxate, octocrylene liquid POUTSCREEN LIP TREATMENT CANDY CANE- avobenzone, octinoxate, octocrylene liquid

PoutScreen Lip Treatment Candy Cane by

Drug Labeling and Warnings

PoutScreen Lip Treatment Candy Cane by is a Otc medication manufactured, distributed, or labeled by NAKED SUNDAYS PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INACTIVE INGREDIENT

PoutScreen Love Letter

Inactive Ingredients: Polybutene, Isopropyl Myristate, Ethylhexyl Methoxycrylene, Octyldodecanol, Pentaerythrityl Tetraisostearate, Flavor, Poly C10-30 Alkyl Acrylate, Silica Silylate, Cocos Nucifera (Coconut) Oil, Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Seed Oil, Sucralose, Polyglutamic Acid, Squalane, Propylene Carbonate, Stearalkonium Hectorite, Solanum Lycopersicum (Tomato) Fruit Extract, Water, BHT, Sorbitan Oleate, Palmitoyl Hexapeptide-12, Titanium Dioxide (CI 77891), Red 7 (CI 15850), Red 6 Lake (CI 15850), Yellow 5 (CI 19140).

PoutScreen Darling

Inactive Ingredients: Polybutene, Isopropyl Myristate, Ethylhexyl Methoxycrylene, Octyldodecanol, Pentaerythrityl Tetraisostearate, Flavor, Poly C10-30 Alkyl Acrylate, Silica Silylate, Cocos Nucifera (Coconut) Oil, Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Seed Oil, Sucralose, Polyglutamic Acid, Squalane, Propylene Carbonate, Stearalkonium Hectorite, Solanum Lycopersicum (Tomato) Fruit Extract, Water, BHT, Sorbitan Oleate, Palmitoyl Hexapeptide-12, Iron Oxide (CI 77491), Yellow 5 (CI 19140), Red 7 (CI 15850), Iron Oxide (CI 77499), Red 6 Lake (CI 15850), Titanium Dioxide (CI 77891).

PoutScreen Midnight Kiss

Inactive Ingredients: Polybutene, Isopropyl Myristate, Ethylhexyl Methoxycrylene, Octyldodecanol, Pentaerythrityl Tetraisostearate, Flavor, Poly C10-30 Alkyl Acrylate, Silica Silylate, Cocos Nucifera (Coconut) Oil, Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Seed Oil, Sucralose, Polyglutamic Acid, Iron Oxides (CI 77491), Squalane, Propylene Carbonate, Stearalkonium Hectorite, Iron Oxides (CI 77499), Red 7 (CI 15850), Titanium Dioxide (CI 77891), Red 6 Lake (CI 15850), Solanum Lycopersicum (Tomato) Fruit/Leaf/Stem Extract, Water, BHT, Yellow 5 (CI 19140), Sorbitan Oleate, Palmitoyl Hexapeptide-12.

PoutScreen Candy Cane

Inactive Ingredients: Polybutene, Isopropyl Myristate, Ethylhexyl Methoxycrylene, Octyldodecanol, Pentaerythrityl Tetraisostearate, Flavor, Poly C10-30 Alkyl Acrylate, Silica Silylate, Cocos Nucifera (Coconut) Oil, Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Seed Oil, Sucralose, Polyglutamic Acid, Squalane, Propylene Carbonate, Stearalkonium Hectorite, Solanum Lycopersicum (Tomato) Fruit Extract, Water, BHT, Sorbitan Oleate, Palmitoyl Hexapeptide-12, Red 7 (CI 15850), Red 6 Lake (CI 15850).

ACTIVE INGREDIENT

PoutScreen Love Letter

Active Ingredients: Avobenzone 2.5% , Octinoxate 7.5%, Octocrylene 10%

PoutScreen Darling

Active Ingredients: Avobenzone 2.5% , Octinoxate 7.5%, Octocrylene 10%

PoutScreen Midnight Kiss

Active Ingredients: Octocrylene 10%, Ethylhexyl Methoxycinnamate 7.5%, Avobenzone 2.5%

PoutScreen Candy Cane

Active Ingredients: Avobenzone 2.5% , Octinoxate 7.5%, Octocrylene 10%

PURPOSE

Sunscreen

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POUTSCREEN LIP TREATMENT MIDNIGHT KISS 
avobenzone, octinoxate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81104-596
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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 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)
CI 19140 (UNII: I753WB2F1M)
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 15850 (UNII: 481744AI4O)
CI 77491 (UNII: 1K09F3G675)
CI 77499 (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81104-596-02	1 in 1 CARTON	12/18/2025
1	NDC: 81104-596-01	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	12/18/2025

POUTSCREEN LIP TREATMENT LOVE LETTER 
avobenzone, octinoxate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81104-595
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)
CI 19140 (UNII: I753WB2F1M)
SOLANUM LYCOPERSICUM (TOMATO) FRUIT (UNII: Z4KHF2C175)
SORBITAN OLEATE (UNII: 06XEA2VD56)
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)
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 15850 (UNII: 481744AI4O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81104-595-02	1 in 1 CARTON	12/18/2025
1	NDC: 81104-595-01	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	12/18/2025

POUTSCREEN LIP TREATMENT DARLING 
avobenzone, octinoxate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81104-597
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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CI 77491 (UNII: 1K09F3G675)
CI 77499 (UNII: XM0M87F357)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
CI 19140 (UNII: I753WB2F1M)
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)
OCTYLDODECANOL (UNII: 461N1O614Y)
SQUALANE (UNII: GW89575KF9)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
CI 15850 (UNII: 481744AI4O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81104-597-02	1 in 1 CARTON	12/18/2025
1	NDC: 81104-597-01	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	12/18/2025

POUTSCREEN LIP TREATMENT CANDY CANE 
avobenzone, octinoxate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81104-598
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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 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)
CI 19140 (UNII: I753WB2F1M)
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 15850 (UNII: 481744AI4O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81104-598-02	1 in 1 CARTON	12/18/2025
1	NDC: 81104-598-01	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	12/18/2025

Labeler - NAKED SUNDAYS PTY LTD (746918845)