LIP BALM ROOT BEER FLAVORED- spf 15 lipstick

Lip Balm Root Beer Flavored by

Drug Labeling and Warnings

Lip Balm Root Beer Flavored by is a Otc medication manufactured, distributed, or labeled by Webb Business Promotions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Purpose

Purpose

Sun Screen

Drug Facts

Octinoxate 3.6%

Octisalate 2.5%

Benzophenone 1.5%

Inactive Ingredients

Hydrogenated Soybean Oil, Sunflower Oil, White Beeswax Pastilles, Cocoa Butter, Shea Butter, Vitamin E, Aloe Vera Gel, Root Beer Flavoring.

Warnings

• Skin Cancer/Skin Aging Alert: Spending too much time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to only help prevent sunburn, not skin cancer or early skin aging.
• For external use only.
• Do not use on damaged or broken skin.
• Stop use and ask doctor if rash occurs.
• When using this product keep out of eyes.
• Keep out of reach of children. If swallowed get medical help or contact posion control center right away.

Directions

• Apply liberally 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• Reapply every 2 hours
• Children under 6 months : Ask a doctor

Storage and Handling Information

Protect this product from excessive heat and direct sun

ROOT BEER FLAVORED SPF 15 NATURAL BEESWAX LIP BALM

INGREDIENTS AND APPEARANCE

LIP BALM ROOT BEER FLAVORED 
spf 15 lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70445-235
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.6 g  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.5 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
COCOA BUTTER (UNII: 512OYT1CRR)
SHEA BUTTER (UNII: K49155WL9Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
WHITE WAX (UNII: 7G1J5DA97F)
SUNFLOWER OIL (UNII: 3W1JG795YI)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	ROOT BEER	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70445-235-01	5 g in 1 TUBE; Type 0: Not a Combination Product	09/11/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2009

Labeler - Webb Business Promotions (154445647)

Establishment
Name	Address	ID/FEI	Business Operations
Webb Business Promotions		154445647	manufacture(70445-235)