EIGHT HOUR CREAM LIP PROTECTANT SPF 15- petrolatum 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.

----------

BL0774

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0774
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1.12 g  in 3.7 g
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O0.296 g  in 3.7 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.111 g  in 3.7 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67938-0774-11 in 1 BOX
1NDC:67938-0774-23.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/31/2006
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 1/2011
Document Id: 1eef0736-09fc-40de-b8c0-a745842f4ea6
Set id: aeeb3768-e03d-43c8-9cd0-7e8a8508b207
Version: 3
Effective Time: 20110114
 
Elizabeth Arden, Inc