Poutscreen Lip Treatment

Manufacturer
NAKED SUNDAYS PTY LTD
Effective date
2026-07-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-17 21:45:49

Label at a glance#

ProductPoutScreen Lip Treatment Tiramisu
Active ingredientOCTINOXATE, OCTOCRYLENE, AVOBENZONE
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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 SECTION

Warnings: For external use only.

• Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor: If rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTC - PURPOSE SECTION

Sunscreen

INACTIVE INGREDIENT SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 79 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PoutScreen Lip Treatment Lemon MeringueAVOBENZONE, OCTINOXATE, OCTOCRYLENENAKED SUNDAYS PTY LTD563e3ab9-4ee2-279c-e063-6294a90a7cf12026-07-10WarningsExact identifier
ndc (package): 81104-605-02
ndc (package): 81104-603-02
ndc (package): 81104-605-01
ndc (package): 81104-604-02
ndc (package): 81104-604-01
ndc (package): 81104-603-01
ndc (product): 81104-603
ndc (product): 81104-604
ndc (product): 81104-605
ndc11 (package): 81104060302
ndc11 (package): 81104060501
ndc11 (package): 81104060402
ndc11 (package): 81104060502
ndc11 (package): 81104060401
ndc11 (package): 81104060301
spl id: 563e3ab9-4ee3-279c-e063-6294a90a7cf1
spl set id: 563e3ab9-4ee2-279c-e063-6294a90a7cf1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.