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

Eight Hour Cream Nourishing Lip Balm SPF 20 by

Drug Labeling and Warnings

Eight Hour Cream Nourishing Lip Balm SPF 20 by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-1111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.568 g  in 14.2 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.426 g  in 14.2 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-1111-1	1 in 1 BOX
1	NDC: 67938-1111-2	14.2 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/24/2012

Labeler - Elizabeth Arden, Inc (849222187)