GAP FAVORITE LIP BALM CREAMY POMEGRANATE SPF 18- octinoxate and oxybenzone stick

GAP Favorite Lip Balm by

Drug Labeling and Warnings

GAP Favorite Lip Balm by is a Otc medication manufactured, distributed, or labeled by Autumn Harp, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active Ingredients                     Purpose

Octinoxate 7.5%                      Sunscreen

Oxybenzone 6%                      Sunscreen

Purpose

• lip moisturizer
• helps prevent sunburn
• higher SPF gives more sunburn protection

Warning

Warnings

For external use only.

When using this product

When using this product keep out of eyes. Rinse with water to remove.

Stop use

Stop use and ask a doctor if rash and irritation develops and lasts

Keep out of reach of children

Keep out of reach of children. If swallowed get medical help or contact Poison Control right away.

Directions

Directions

• apply liberally before sun exposure and as needed
• children under 6 months of age: ask doctor

Sun Alert

Other information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin cancer, and other harmful effects of the sun.

Inactive Ingredients

Inactive Ingredients:  Hydrogenated Coconut Oil, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Flavor, Olea Europaea (Olive) Fruit Oil, Tocopheryl Acetate, Ammonium Glycyrrhizate, Glycine Soja (Soybean) Oil, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Tocopherol, Lecithin, Rosmarinus Officinalis (Rosemary) Leaf Extract.

Label

INGREDIENTS AND APPEARANCE

GAP FAVORITE LIP BALM  CREAMY POMEGRANATE SPF 18
octinoxate and oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0214
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
OLIVE OIL (UNII: 6UYK2W1W1E)
YELLOW WAX (UNII: 2ZA36H0S2V)
CANDELILLA WAX (UNII: WL0328HX19)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
TOCOPHEROL (UNII: R0ZB2556P8)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ROSEMARY (UNII: IJ67X351P9)
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)

Product Characteristics
Color		Score
Shape		Size
Flavor	FRUIT (Pomegranate)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0214-1	4 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/21/2011

Labeler - Autumn Harp, Inc (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Inc		064187883	manufacture