Eight Hour Cream Lip Protectant SPF 15

Dosage form: stick
Ingredients: PETROLATUM 1.12g in 3.7g, PADIMATE O 0.296g in 3.7g, OXYBENZONE 0.111g in 3.7g
Labeler: Elizabeth Arden, Inc
NDC Code: 67938-0774

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 SPF 15 
petrolatum stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0774
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM1.12 g  in 3.7 g
PADIMATE O (PADIMATE O) PADIMATE O0.296 g  in 3.7 g
OXYBENZONE (OXYBENZONE) OXYBENZONE0.111 g  in 3.7 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL 
MYRISTYL LACTATE 
OXYBENZONE 
CANDELILLA WAX 
YELLOW WAX 
MICROCRYSTALLINE WAX 
PROPYLPARABEN 
BUTYLPARABEN 
CORN OIL 
ALPHA-TOCOPHEROL 
BUTYLATED HYDROXYTOLUENE 
Packaging
#Item CodePackage Description
1NDC:67938-0774-11 TUBE (1 TUBE) 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: 01/2011
 
Elizabeth Arden, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)