EIGHT HOUR CREAM LIP PROTECTANT SHEER TINT SPF 15 HONEY - 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.

----------

DESCRIPTION

Moisturizes, softens and smooths lips. Provides antioxidant protection with vitamin E. SPF 15 protects against UV exposure. Provides a sheer wash of color in 6 translucent shades. Dermatologist, clinically and allergy tested.

INDICATIONS AND USAGE

To Use: Apply liberally as often as necessary.

WARNINGS

Warning: If condition worsens or does not improve within 7 days, consult a physician.

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: Ozokerite, Ricinus Communis (Castor) Seed Oil, Glyceryl Rosinate, Cetyl Lactate, Lanolin Oil, Myristyl Lactate, Cetyl Acetate, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera/Cire De Candelilla, Copernicia Cerifera (Carnauba) Wax/Cer 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/Huile Vegetale, Zea Mays (Corn) Oil, Citral Citronellol, Geraniol, Limonene, Linalool, Butylparaben, Propylparaben.

May Contain: Blue 1 Lake (CI 42090), Iron Oxides (CI 77491, CI 77499, CI 77492), Red 6 Lake (CI 15850), Red 7 Lake (CI 15850), Red 21 Lake (CI 45380), Red 27 Lake (CI 45410), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Yellow 6 Lake (CI15985).

DOSAGE & ADMINISTRATION

Apply to lips.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTC - PURPOSE

SPF 15 protects against UV exposure.

OTC - WHEN USING

Note condition.

Eight Hour Cream Lip Protectant Stick Sheer Tint Box

Eight Hour Cream Lip Protectant Stick Sheer Tint Base Label

EIGHT HOUR CREAM LIP PROTECTANT SHEER TINT SPF 15 HONEY
petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67938-1407
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (PETROLATUM)	PETROLATUM	1.117 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	0.392 g in 3.7 g
MYRISTYL LACTATE	0.203 g in 3.7 g
CANDELILLA WAX	0.079 g in 3.7 g
YELLOW WAX	0.037 g in 3.7 g
MICROCRYSTALLINE WAX	0.016 g in 3.7 g
BUTYLPARABEN	0.0074 g in 3.7 g
PROPYLPARABEN	0.0037 g in 3.7 g
BUTYLATED HYDROXYTOLUENE	0.0018 g in 3.7 g
ALPHA-TOCOPHEROL	0.00022 g in 3.7 g
CORN OIL	4e-005 g in 3.7 g

Product Characteristics
Color	YELLOW (Honey)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:67938-1407-1	1 TUBE (1 TUBE) in 1 BOX	contains a TUBE (67938-1407-2)
1	NDC:67938-1407-2	3.7 g in 1 TUBE	This package is contained within the BOX (67938-1407-1)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/28/2006

Labeler - Elizabeth Arden, Inc (849222187)

Establishment
Name	Address	ID/FEI	Operations
CEI		032565959	manufacture

Revised: 01/2011 Elizabeth Arden, Inc