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  5. Label Information: Eight Hour Cream Nourishing Lip Balm Spf 20

FDA Label for Eight Hour Cream Nourishing Lip Balm Spf 20

View Indications, Usage & Precautions

Table of Contents

    1. DESCRIPTION
    2. INDICATIONS AND USAGE
    3. WARNINGS
    4. OTC - ACTIVE INGREDIENT
    5. INACTIVE INGREDIENT
    6. DOSAGE & ADMINISTRATION
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. OTC - PURPOSE
    9. OTC - WHEN USING

Eight Hour Cream Nourishing Lip Balm Spf 20 Product Label

The following document was submitted to the FDA by the labeler of this product Elizabeth Arden, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


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