Naked Sundays PoutScreen Plumping Lip Treatment Marshmallow 10mL

Manufacturer
Northwest Cosmetic Laboratories LLC, DBA Elevation Labs, Idaho -
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:51:57

Label at a glance#

ProductNaked Sundays PoutScreen Plumping Lip Treatment Marshmallow 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,Mica,Hydrogenated Polyisobutene,Palmitic Acid , Titanium Dioxide (Cl 77891), Simmondsia Chinensis (Jojoba) Seed Oil, Solanum Lycopersicum
(Tomato) Fruit Extract, Titanium Dioxide (CI 77891).
Red 40 (Cl 16035) 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

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62282-24962282-249-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
24b06bb4-e7d9-b6e0-e063-6394a90a308b24b088f3-efbe-d0c2-e063-6394a90a910f2024-10-17WarningsExact identifier
spl id: 24b06bb4-e7d9-b6e0-e063-6394a90a308b
spl set id: 24b088f3-efbe-d0c2-e063-6394a90a910f

Reported adverse events (FAERS/openFDA)#

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