INTERVENE DAILY MOISTURE SPF 15 OIL FREE - octinoxate and oxybenzone lotion
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 lightweight, oil free moisturizing lotion, powered by alpha and beta hydroxy compounds, refines, clarifies and retexturizes skin for a naturally radiant appearance. SPF 15 UVA/UVB sunscreens and antioxidant vitamins C and E protect skin from sun and pollution while an advanced hydrating system helps keep skin soft, smooth, and healthy looking all day long. Sensitive skin tested. Oil Free. Clinically, dermatologist and allergy tested.

INDICATIONS AND USAGE

To Use: Apply daily to face and throat before sun exposure.

WARNINGS

Warning: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rash appear. If irritation or rash persists, consult a doctor. Keep out of reach of children.

OTC - ACTIVE INGREDIENT

Active Ingredients: Octinoxate 6.0% w/w, Oxybenzone 3.0% w/w.

INACTIVE INGREDIENT

Other Ingredients: Water/Aqua/Eau, Dimethicone, Isononyl Isononanoate, Glycerin, Tridecyl Salicylate, Steareth-21, Isostearic Acid, Octyldodecyl Neopentanoate, Aluminum Starch Octenylsuccinate, Algae Extract, Slavia Officinalis (Sage) Leaf Extract, Sodium Hyaluronate, Sodium Lactate, Retinyl Linoleate, Tetrahexyldecyl Ascorbate, Tocopherol, Glyceryl Stearate, Propylene Glycol, Panthenol, C12-20 Acid PEG-8 Ester, Cetyl Alcohol, PEG-100 Stearate, Trilaureth-4 Phosphate, Steareth-2, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylene/VA Copolymer, Sclerotium Gum, Triethanolamine, Disodium EDTA, Parfum/Fragrance, Butylphenyl Methylpropional, Citronellol, Hexyl Cinnamal, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool, DMDM Hydantoin, Methylparaben, Propylparaben.

DOSAGE & ADMINISTRATION

Apply to face and throat.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTC - PURPOSE

SPF 15 UVA/UVB sunscreens protect skin from sun.

OTC - WHEN USING

Avoid contact with eyes.

Intervene daily Moisture Lotion Oil Free Carton

INTERVENE DAILY MOISTURE SPF 15 OIL FREE
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67938-0577
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (OCTINOXATE)	OCTINOXATE	3 mL in 50 mL
OXYBENZONE (OXYBENZONE)	OXYBENZONE	1.5 mL in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER	31.8 mL in 50 mL
DIMETHICONE	3.6 mL in 50 mL
ISONONYL ISONONANOATE	2.25 mL in 50 mL
GLYCERIN	1.5 mL in 50 mL
ISOSTEARIC ACID	0.6 mL in 50 mL
STEARETH-21	0.6 mL in 50 mL
ALUMINUM STARCH OCTENYLSUCCINATE	0.5 mL in 50 mL
OCTYLDODECYL NEOPENTANOATE	0.5 mL in 50 mL
GLYCERYL MONOSTEARATE	0.425 mL in 50 mL
PEG-100 STEARATE	0.425 mL in 50 mL
CETYL ALCOHOL	0.4 mL in 50 mL
PANTHENOL	0.25 mL in 50 mL
TROLAMINE	0.175 mL in 50 mL
SODIUM LACTATE	0.15 mL in 50 mL
STEARETH-2	0.15 mL in 50 mL
TETRAHEXYLDECYL ASCORBATE	0.1 mL in 50 mL
DMDM HYDANTOIN	0.0825 mL in 50 mL
METHYLPARABEN	0.08 mL in 50 mL
PROPYLENE GLYCOL	0.06 mL in 50 mL
PROPYLPARABEN	0.05 mL in 50 mL
EDETATE DISODIUM	0.05 mL in 50 mL
SAGE	0.0195 mL in 50 mL
ALPHA-TOCOPHEROL	0.5 mL in 50 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:67938-0577-1	1 JAR (1 JAR) in 1 BOX	contains a JAR (67938-0577-2)
1	NDC:67938-0577-2	50 mL in 1 JAR	This package is contained within the BOX (67938-0577-1)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/15/2009

Labeler - Elizabeth Arden, Inc (849222187)

Establishment
Name	Address	ID/FEI	Operations
CEI		032565959	manufacture

Revised: 01/2011 Elizabeth Arden, Inc