Active Ingredients
Active Ingredients:
AVOBENZONE 3%
HOMOSALATE 10%
OCTISALATE 5%
OCTOCRYLENE 10%
Naked Sundays Poutscreen Plumping Lip Treatment Marshmallow 10ml Liquid
FDA Label NDC 81104-249
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Naked Sundays Pty Ltd for the product Naked Sundays Poutscreen Plumping Lip Treatment Marshmallow 10ml (NDC 81104-249). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - Keep Out Of Reach Of Children
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.
- Limit time in the sun, especially from 10.00AM - 2.00PM
- Wear long-sleeved shirts, pants, hats, and sunglasses
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:
Inactive Ingredients
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 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
Otc - Purpose
Sunscreen
* Please review the disclaimer below.
