PETROLEUM-FREE LIP BALM- octinoxate and oxybenzone lipstick

Petroleum-Free Lip Balm by

Drug Labeling and Warnings

Petroleum-Free Lip Balm by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 2.0%

Oxybenzone 4.5%

Purpose

Sunscreen

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.

SPL UNCLASSIFIED SECTION

©2019 CURAD and Medline are registered trademarks of Medline Industries, Inc. Manufactured for Medline Industries, Inc. Three Lakes Drive, Northfield, IL 60093. Made in USA of foreign and domestic materials. RG19OLB Visit us at www.curad.com or call: 1-800-633-5463

Package Label

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2010

Labeler - Medline Industries, Inc. (025460908)