FDA.reportPublic FDA data

Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mL

Manufacturer
NAKED SUNDAYS PTY LTD
Effective date
2025-03-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:58:11

Label at a glance#

ProductNaked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mL
Active ingredientHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE
Label structure8 sections

Indications and 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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

AVOBENZONE 3%

HOMOSALATE 10%

OCTISALATE 5%

OCTOCRYLENE 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

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 SECTION

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.

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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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, Mica, Titanium Dioxide (CI 77891).
Red 6 Lake (Cl 15850) Polyglutamic Acid Water, Sucralose

OTHER INFORMATION

OTHER SAFETY INFORMATION

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

USER SAFETY WARNINGS SECTION

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

OTC - PURPOSE SECTION

Sunscreen

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81104-248-01Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mL10 mL in 1 TUBE, WITH APPLICATORLIQUID103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81104-248NAKED SUNDAYS POUTSCREEN PLUMPING LIP TREATMENT COTTON CANDY 10ML (LIP TREATMENT) LIQUID [NAKED SUNDAYS PTY LTD]3Current NDC, 1 package rows20250402_24a7bee2-3802-4786-e063-6294a90a6ab5.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81104-24881104-248-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
SUCRALOSE96K6UQ3ZD4IACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
OCTYLDODECANOL461N1O614YIACT
D&C RED NO. 6481744AI4OIACT
WATER059QF0KO0RIACT
COCONUT OILQ9L0O73W7LIACT
POLYGLUTAMIC ACID (1200 MW)MGE3733FR2IACT
SQUALANEGW89575KF9IACT
JOJOBA OIL724GKU717MIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
SOLANUM LYCOPERSICUM0243Q4990LIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB

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
Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD24a7bee2-3802-4786-e063-6294a90a6ab52025-03-22WarningsExact identifier
ndc (package): 81104-248-01
ndc (product): 81104-248
ndc11 (package): 81104024801
spl id: 30f0dd7c-d029-8374-e063-6394a90affeb
spl set id: 24a7bee2-3802-4786-e063-6294a90a6ab5

Reported adverse events (FAERS/openFDA)#

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