Drugplain

Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mL 3 g/100mL

Lip Treatment · LIQUID · NAKED SUNDAYS PTY LTD

No Recall History
Plain English

I need to clarify that this product is not FDA-approved as a drug. Naked Sundays Poutscreen Plumping Lip Treatment is an over-the-counter cosmetic lip product designed to condition and plump the lips when applied topically.

Key Facts

Brand Name
Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mL
Generic Name
Lip Treatment
NDC Code (Product)
81104-248
Manufacturer
NAKED SUNDAYS PTY LTD
Strength
3 g/100mL
Dosage Form
LIQUID
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
10/16/2024

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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.

Dosage & Administration

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

Warnings

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

Frequently Asked Questions

What is Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mL used for?

I need to clarify that this product is not FDA-approved as a drug. Naked Sundays Poutscreen Plumping Lip Treatment is an over-the-counter cosmetic lip product designed to condition and plump the lips when applied topically.

Is Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mL a controlled substance?

Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mL is not classified as a controlled substance by the DEA.

What is the generic name for Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mL?

The generic name for Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mL is Lip Treatment. There are 3 other brand versions of Lip Treatment.

What is the NDC code for Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mL 3 g/100mL?

The NDC (National Drug Code) for Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mL 3 g/100mL is 81104-248, listed by NAKED SUNDAYS PTY LTD.