EIGHT HOUR CREAM NOURISHING LIP BALM SPF 20- octinoxate and avobenzone salve 
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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DESCRIPTION

This daily moisturizing treatment replenishes lips with eight essential vitamins, nutrients and

minerals while providing advanced broad spectrum SPF 20 sun protection against damaging

UVA/UVB rays.

INDICATIONS AND USAGE

To use: Squeeze tube and apply liberally with self-applicator tip.

WARNINGS

WARNING

:

FOR EXTERNAL USE ONLY. DO NOT USE

ON DAMAGED OR BROKEN SKIN. WHEN USING

THIS PRODUCT KEEP OUT OF EYES. RINSE WITH

WATER TO REMOVE. STOP USE AND ASK A

DOCTOR IF RASH OCCURS. KEEP OUT OF REACH

OF CHILDREN. IF PRODUCT IS SWALLOWED, GET

MEDICAL HELP OR CONTACT A POISON CONTROL

CENTER RIGHT AWAY.

 

OTC - ACTIVE INGREDIENT

ACTIVE INGREDIENTS: OCTINOXATE, 4.0 % W/W

AVOBENZONE, 3.0 % W/W

INACTIVE INGREDIENT

Inactive Ingredients

POLYBUTENE, MICROCRYSTALLINE WAX/CERA

MICROCRISTALLINA/CIRE MICROCRISTALLINE,

PETROLATUM, RICINUS COMMUNIS (CASTOR)

SEED OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER,

NYLON-12, DIOCTYLDODECYL DODECANEDIOATE, C12-15

ALKYL BENZOATE, GLYCERETH-26, BUTYLOCTYL

SALICYLATE, LANOLIN, ASTROCARYUM MURUMURU

SEED BUTTER, BEESWAX/CERA ALBA/CIRE D'ABEILLE,

COPERNICIA CERIFERA (CARNAUBA) WAX/CERA

CARNAUBA/CIRE DE CARNAUBA, HELIANTHUS ANNUUS

(SUNFLOWER) SEED OIL, HONEY EXTRACT,

HYDROGENATED CASTOR OIL, LINOLEIC ACID, LINOLENIC

ACID, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT,

RETINYL PALMITATE, TOCOPHEROL, TOCOPHERYL

ACETATE, BHT, IRON OXIDES (CI 77491, CI 77492).

DOSAGE & ADMINISTRATION

apply liberally

OTC - KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

OTC - PURPOSE

Provides SPF 20 sun protection.

OTC - WHEN USING

KEEP OUT OF EYES.

EHCNLB - CARTON
EHCNLB - insert
EHCNLB - onsert
EHCNLB - tube
EIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 
octinoxate and avobenzone salve
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.568 g  in 14.2 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.426 g  in 14.2 g
Inactive Ingredients
Ingredient NameStrength
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PETROLATUM (UNII: 4T6H12BN9U)  
NYLON-12 (UNII: 446U8J075B)  
DIOCTYLDODECYL DODECANEDIOATE (UNII: 7QDB5EE79Y)  
GLYCERETH-26 (UNII: NNE56F2N14)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
LANOLIN (UNII: 7EV65EAW6H)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
LINOLENIC ACID (UNII: 0RBV727H71)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67938-1111-11 in 1 BOX
1NDC:67938-1111-214.2 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/24/2012
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 5/2013
Document Id: 97dab94c-6a46-48c9-9427-68be6eb6e103
Set id: a6271ee2-39c2-445a-bb24-f87745ac69be
Version: 1
Effective Time: 20130502
 
Elizabeth Arden, Inc