LIP BALM SPEARMINT FLAVORED- spf 15 lipstick
Webb Business Promotions

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SPF 15 Lip Balm Spearmint Flavored

Purpose

Sun Screen

Drug Facts

Octinoxate 3.6%

Octisalate 2.5%

Benzophenone 1.5%

Inactive Ingredients

Hydrogenated Soybean Oil, Sunflower Oil, Yellow Bees Wax Pearls, Cocoa Butter, Shea Butter, Vitamin E, Aloe Vera Gel, Spearmint 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

SPF15 NATURAL BEESWAX LIP BALM SPEARMINT FLAVORED

Spear LB60

LIP BALM SPEARMINT FLAVORED
spf 15 lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70445-109
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

Product Characteristics
Color	white	Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70445-109-01	5 g in 1 TUBE; Type 0: Not a Combination Product	09/11/2009	11/03/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	01/01/2009	11/03/2016

Labeler - Webb Business Promotions (154445647)

Name	Address	ID/FEI	Business Operations
Establishment
Webb Business Promotions		154445647	manufacture(70445-109)

Revised: 11/2016

Document Id: 406a7bc0-c8a1-4b01-e054-00144ff88e88

Set id: 2d17e9bd-0431-370b-e054-00144ff8d46c

Version: 4

Effective Time: 20161103

Webb Business Promotions