EIGHT HOUR CREAM LIP PROTECTANT SPF 15- petrolatum stick

Eight Hour Cream Lip Protectant SPF 15 by

Drug Labeling and Warnings

Eight Hour Cream Lip Protectant SPF 15 by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

An all weather treatment stick for softer, smoother lips. Sunscreen ingredients (SPF 15) guard against the damaging effects of sun exposure. Dermatologist, clinically and allergy tested.

INDICATIONS AND USAGE

Apply to lips.

WARNINGS

Warnings: Discontinue use if signs of irritation or rash appear and see a doctor. Keep out of reach of children.

OTC - ACTIVE INGREDIENT

Active Ingredients: Petrolatum 30.2% w/w, Padimate O 8.0% w/w, Oxybenzone 3.0% w/w.

INACTIVE INGREDIENT

Other Ingredients: Ricinus Communis (Castor) Seed Oil, Ozokerite, Glyceryl Rosinate, Cetyl Lactate, Myristyl Lactate, Lanolin Oil, Cetyl Acetate, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera/Cire de Candelilla, Copernicia Cerifera (Carnauba) Wax/Cera Carnauba/Cire De Carnauba, Beeswax/Cera Alba/Cire D'Abeille, Tocopherol, Acetylated Lanolin Alcohol, Methylstyrene/Vinyltoluene Copolymer, Microcrystalline Wax/Cera Microcristallina/Cire Microcristalline, BHT, Vegetable Oil/Olus/Huille Vegetale, Zea Mays (Corn) Oil, Parfum/Fragrance, Citral, Citronellol, Geraniol, Limonene, Linalool, Butylparaben, Propylparaben, Iron Oxides.

DOSAGE & ADMINISTRATION

Apply to lips.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTC - PURPOSE

Protects skin. Provides SPF 15 sun protection.

OTC - WHEN USING

Discontinue use if signs of irritation or rash appear.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EIGHT HOUR CREAM LIP PROTECTANT SPF 15 
petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-0774
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	1.12 g  in 3.7 g
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)	PADIMATE O	0.296 g  in 3.7 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.111 g  in 3.7 g

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
MYRISTYL LACTATE (UNII: 1D822OC34X)
OXYBENZONE (UNII: 95OOS7VE0Y)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CORN OIL (UNII: 8470G57WFM)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-0774-1	1 in 1 BOX
1	NDC: 67938-0774-2	3.7 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/31/2006

Labeler - Elizabeth Arden, Inc (849222187)