Eight Hour Cream Lip Protectant Sheer Tint SPF 15 Melon

Dosage form: stick
Ingredients: PETROLATUM 1.117g in 3.7g, PADIMATE O 0.296g in 3.7g, OXYBENZONE 0.111g in 3.7g
Labeler: Elizabeth Arden, Inc
NDC Code: 67938-1470

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.

BL1470

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EIGHT HOUR CREAM LIP PROTECTANT SHEER TINT SPF 15 MELON 
petrolatum stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1470
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM1.117 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 
CANDELILLA WAX 
YELLOW WAX 
MICROCRYSTALLINE WAX 
BUTYLPARABEN 
PROPYLPARABEN 
BUTYLATED HYDROXYTOLUENE 
ALPHA-TOCOPHEROL 
CORN OIL 
Product Characteristics
ColorORANGE (Melon) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:67938-1470-11 TUBE (1 TUBE) in 1 BOX
1NDC:67938-1470-23.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/28/2006
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.

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