Drug Facts

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.

Warnings

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.

For external use only

Do not use on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if rash occurs

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

Manufactured for

Gadi's Ingenious Gadgets Inc.

Brooklyn NY 11218

(718) 831-2626

www.LipBalmRing.com

Made in China

Designed in the U.S.

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

Front

Back

GADIS LIP MOISTURIZER SPF15
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69065-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7 g in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SUNFLOWER OIL (UNII: 3W1JG795YI)
OLIVE OIL (UNII: 6UYK2W1W1E)
YELLOW WAX (UNII: 2ZA36H0S2V)
CANDELILLA WAX (UNII: WL0328HX19)
2-BUTYLOCTYL METHACRYLATE (UNII: C927XK2YP0)
SHEANUT OIL (UNII: O88E196QRF)
MACADAMIA OIL (UNII: 515610SU8C)
CARNAUBA WAX (UNII: R12CBM0EIZ)

#	Item Code	Package Description
Packaging
1	NDC:69065-001-02	1.4 g in 1 CARTON
2	NDC:69065-001-04	2.8 g in 1 CARTON

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/06/2014

Labeler - Gadis Ingenious Gadgets Inc. (037630799)