Gadis Lip Moisturizer
FDA Label NDC 69065-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gadis Ingenious Gadgets Inc. for the product Gadis Lip Moisturizer (NDC 69065-001). 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 other, active ingredients, purpose, use, skin cancer/skin aging alert, otc - do not use, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

For external use only

Manufactured for

Gadi's Ingenious Gadgets Inc.

Brooklyn NY 11218

(718) 831-2626

www.LipBalmRing.com

Made in China

Designed in the U.S.

Active Ingredients

Octinoxate 7%
Oxybenzone 3%

Purpose

Sunscreen

Use

  • Helps prevent sunburn

  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Otc - Do Not Use

Do not use on damaged or broken skin

When Using This Product

keep out of eyes. Rinse with water to remove

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

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

Directions

  • apply liberally and evenly 15 minutes before sun exposure.

  • 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 a.m. – 2 p.m.

  • Wear long-sleeved shirts, pants, hats

    and sunglasses

  • Reapply:

  • After 40 minutes swimming or

    sweating

  • Immediately after towel drying

  • At least every 2 hours

  • Children under 6 months of age: Ask

    a doctor

Other Information

  • Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

sunflower oil, olive

oil, beeswax, candelilla wax, carnauba

wax, octyl methoxycinnamate, shea oil,

macadamia oil, fragrance, tocopherol

acetate

Gadis Lip Moisturizer Spf 15

gadi's

Lip Moisturizer Ring

Sunscreen Broad Spectrum SPF 15

Water Resistant (40 minutes)

MOISTURIZES, SOOTHES,

AND HYDRATES DRY LIPS.

RECOMMENDED FOR USE

DURING OUTDOOR SPORTS.

4 RING INSERTS

NET WT. 0.1 OZ (2.8 G)

Front2 (Front2)

Front2 (Front2)

Front (Front)

Front (Front)

Back (Back)

Back (Back)

* Please review the disclaimer below.