Poutscreen Lip Treatment

Poutscreen Lip Treatment
SPL v1
SPL
SPL Set ID 47d22c6d-49fd-f97c-e063-6294a90a6ba1
Route
TOPICAL
Published
Effective Date 2025-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Avobenzone (2.5 g) Octocrylene (10 g)
Inactive Ingredients
Isopropyl Myristate Cocos Nucifera (coconut) Oil Stearalkonium Hectorite Palmitoyl Hexapeptide-12 Ci 19140 Solanum Lycopersicum (tomato) Fruit Polyglutamic Acid (1200 Mw) Sucralose Water Silica Dimethyl Silylate Polybutene (1400 Mw) Ethylhexyl Methoxycrylene Sorbitan Oleate Ci 77891 Squalane Propylene Carbonate Pentaerythrityl Tetraisostearate Octyldodecanol Behenyl Acrylate Polymer Caprylic/capric Triglyceride Simmondsia Chinensis (jojoba) Seed Oil Ci 15850 Ci 77491 Ci 77499

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-18
Description

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

Medication Information

Warnings and Precautions

Warnings: For external use only.

• Do not use on damaged or broken skin.

Indications and 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

Dosage and 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

Description

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

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor: If rash occurs.

Section 50567-7

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

Section 51727-6

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).

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

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%

Section 60561-8

Other Information:

• Protect this product from excess heat and direct sun.

• Store below 30°C / 86°F

Questions:

• [email protected]

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings: For external use only.

• Do not use on damaged or broken skin.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor: If rash occurs.

Section 50567-7 (50567-7)

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

Section 51727-6 (51727-6)

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).

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

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%

Section 60561-8 (60561-8)

Other Information:

• Protect this product from excess heat and direct sun.

• Store below 30°C / 86°F

Questions:

• [email protected]

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:08.191531 · Updated: 2026-03-14T23:12:17.704012