EIGHT HOUR CREAM LIP PROTECTANT SPF 15 - petrolatum, padimate o and oxybenzone stick
Elizabeth Arden, Inc

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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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.

Eight Hour Cream Lip Protectant Stick Box

Eight Hour Cream Lip Protectant Stick Base Label

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	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (PETROLATUM)	PETROLATUM	1.12 g in 3.7 g
PADIMATE O (PADIMATE O)	PADIMATE O	0.296 g in 3.7 g
OXYBENZONE (OXYBENZONE)	OXYBENZONE	0.111 g in 3.7 g

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL	0.44 g in 3.7 g
MYRISTYL LACTATE	0.203 g in 3.7 g
OXYBENZONE	0.111 g in 3.7 g
CANDELILLA WAX	0.08 g in 3.7 g
YELLOW WAX	0.037 g in 3.7 g
MICROCRYSTALLINE WAX	0.016 g in 3.7 g
PROPYLPARABEN	0.008 g in 3.7 g
BUTYLPARABEN	0.004 g in 3.7 g
CORN OIL	0.00035 g in 3.7 g
ALPHA-TOCOPHEROL	0.00013 g in 3.7 g
BUTYLATED HYDROXYTOLUENE	9e-005 g in 3.7 g

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:67938-0774-1	1 TUBE (1 TUBE) in 1 BOX	contains a TUBE (67938-0774-2)
1	NDC:67938-0774-2	3.7 g in 1 TUBE	This package is contained within the BOX (67938-0774-1)

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)

Establishment
Name	Address	ID/FEI	Operations
CEI		032565959	manufacture

Revised: 01/2011 Elizabeth Arden, Inc