LIP BALM MANGO 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 Mango Flavored

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, Mango 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

MANGO FLAVORED SPF 15 NATURAL BEESWAX LIP BALM

Mango

LIP BALM MANGO FLAVORED
spf 15 lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70445-245
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
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)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70445-245-01	5 g in 1 TUBE; Type 0: Not a Combination Product	09/11/2009

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

Labeler - Webb Business Promotions (154445647)

Name	Address	ID/FEI	Business Operations
Establishment
Webb Business Promotions		154445647	manufacture(70445-245)