NAKED SUNDAYS POUTSCREEN PLUMPING LIP TREATMENT VANILLA CONFETTI 10ML- lip treatment liquid

Naked Sundays PoutScreen Plumping Lip Treatment VANILLA CONFETTI 10mL by

Drug Labeling and Warnings

Naked Sundays PoutScreen Plumping Lip Treatment VANILLA CONFETTI 10mL by is a Otc medication manufactured, distributed, or labeled by NAKED SUNDAYS PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Active Ingredients:

AVOBENZONE 3%

HOMOSALATE 10%

OCTISALATE 5%

OCTOCRYLENE 10%

Purpose

Sunscreen

USES

Uses: 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 Avoid prolonged
sun exposure. If it gets in your eyes, wash well
with water. Keep out of reach of children.
Stop use and ask a doctor if rashes occur.
If product is swallowed, get medical help or
contact a Poison Control Center right away.

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

DIRECTIONS

• SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE.
• Reapply after 80 minutes of swimming or sweating.
• Reapply immediately after towel drying.
• Reapply at least every 2 hours.
• Children under 3 years 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

INACTIVE INGREDIENTS

Polybutene, Isopropyl Myristate, Octyldodecanol, Poly C10-30
Alkyl Acrylate, Silica Silylate Flavor, Cocos Nucifera
(Coconut) Oil,Silica, , Titanium Dioxide (Cl 77891), Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Solanum Lycopersicum
(Tomato) Fruit Extract, Calcium Sodium Borosilicate
Polyglutamic Acid Water, Sucralose

OTHER INFORMATION

Other Information: Protect this product
from excess heat and direct sun. Store below
30°C / 86°F.

USER SAFETY WARNINGS

Directions: "Apply generously 15 minutes before sun exposure. Reapply 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 10AM - 2PM
Wear long-sleeved shirts, pants, hats, and sunglasses

PURPOSE

Sunscreen

Label

INGREDIENTS AND APPEARANCE

NAKED SUNDAYS POUTSCREEN PLUMPING LIP TREATMENT VANILLA CONFETTI 10ML 
lip treatment liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81104-250
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
OCTYLDODECANOL (UNII: 461N1O614Y)
WATER (UNII: 059QF0KO0R)
COCONUT OIL (UNII: Q9L0O73W7L)
POLYGLUTAMIC ACID (1200 MW) (UNII: MGE3733FR2)
SQUALANE (UNII: GW89575KF9)
JOJOBA OIL (UNII: 724GKU717M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SOLANUM LYCOPERSICUM (UNII: 0243Q4990L)
CALCIUM SODIUM BOROSILICATE (UNII: 4MM76N4WMY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81104-250-01	10 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	10/16/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/16/2024

Labeler - NAKED SUNDAYS PTY LTD (746918845)