Active ingredients

Octinoxate 2.0%

Oxybenzone 4.5%

Purpose

Sunscreen

Use

helps protect against sunburn and chapped lips

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 or irritation develops and lasts

Keep out of reach of children.

If swallowed, get medical help of contact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply at least every 2 hours
children under 6 months: ask a doctor

Other Information

protect this product from excessive heat and direct sun
to report a suspected adverse reaction, contact Curad.

Inactive ingredients

beeswax, BHT, cocos nucifera (coconut) oil, flavor, helianthus annuus (sunflower) seed oil, lanolin, melaleuca alternifolia (tea tree) leaf oil, ricinus communis (castor) seed oil, tocopheryl acetate, zea mays (corn) oil.

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA of foreign and domestic materials

www.curad.com

1-800-633-5463

REF: CUR0415

V1 RD22OLB

Package Label

Label V1 RD22OLB

PETROLEUM-FREE LIP BALM
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-092
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 g in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CASTOR OIL (UNII: D5340Y2I9G)
LANOLIN (UNII: 7EV65EAW6H)
COCONUT OIL (UNII: Q9L0O73W7L)
CORN OIL (UNII: 8470G57WFM)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TEA TREE OIL (UNII: VIF565UC2G)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53329-092-83	1 in 1 BOX	04/01/2010
1		4.2 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	04/01/2010

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)

092 Curad Petroleum-Free Lip Balm