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

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BL1408

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

Sheer Tint Box

Sheer Tint Base Label

EIGHT HOUR CREAM LIP PROTECTANT SHEER TINT SPF 15 BLUSH 
petrolatum stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1408
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1.117 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)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
CORN OIL (UNII: 8470G57WFM)  
Product Characteristics
ColorRED (Blush) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67938-1408-11 in 1 BOX
1NDC:67938-1408-23.7 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: 1/2011
Document Id: c1dc4abb-217c-4c63-9e38-02b17d42e199
Set id: b8397ddc-8fc7-442d-847c-e7ba382d2d2d
Version: 3
Effective Time: 20110114
 
Elizabeth Arden, Inc