INTERVENE RADIANCE BOOSTIN MOISTURE SPF 15 - octinoxate, avobenzone and oxybenzone cream
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 multi-benefit moisturizer immediately boosts skin's appearance for a radiant, clearn, natural looking glow. With continued use, naturally-derived Biodormin technology supports skin's natural cell metabolism rate to help fight the visible aging effects caused by stress. Helps minimize the look of fine lines and combat the appearance of new ones. Provides deep hydration so skin stays younger looking longer. Clinically, dermatologist and allergy tested.

INDICATIONS AND USAGE

To Use: Smooth on to cleansed face and throat daily before sun exposure.

WARNINGS

Warning: For extrenal used 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 7.5% w/w, Avobenzone 3.0% w/w, Oxybenzone 3.0% w/w.

INACTIVE INGREDIENT

Other Ingredients: Water/Aqua/Eau, Ethylhexyl Methoxycinnamate, Glycerin, Butylene Glycol, Isononyl Isononanoate, Dimethicone, Cetearyl Glucoside, Benzophenone-3, Butyl Methoxydibenzoylmethane, Pentylene Glycol, Butyl Stearate, Tidecyl Salicylate, Cetyl Ricinoleate, Cyclopentasiloxane, Narcissus Tazetta Bulb Extract, Triolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Tocopherold, Tocopheryl Acetate, Caprylyl Glycol, Cetearyl Dimethicone Crosspolymer, Ethylhexyl Palmitate, Glyceryl Stearate, Sodium PCA, Trehalose, Urea, Hydrolyzed Soy Protein, Lecithin, Palmitoyl Tetrapeptide-7, Phospholipids, Polyphosphorylcholine Glycol Acrylate, Ammonium Acryloyldimethyltaurate/VP Copolymer, PEG-100 Stearate, PEG-8 Laurate, Steareth-20, PEG-60 Hydrogenated Castor Oil, Sodium Dodecylbenzenesulfonate, Polyquaternium-51, Styrene/Acrylates Copolymer, Hexylene Glycol, Isododecane, PEG-8, Zanthan Gum, Nylon-12, Disodium EDTA, Mica, Tin Oxide, Silica Dimethyl Silylate, Parfum/Fragrance, Butylphenyl Methylpropional, Citronellol, Limonene, Linalool, Benzoic Acid, Methylparaben, Phenoxyethanol, Postassium Sorbate, Propylparaben, Sorbic Acid, Chlorhexidine Digluconate, Chlorphenesin, Titanium Dioxide (CI 77891).

DOSAGE & ADMINISTRATION

Smooth on to face and throat.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTC - PURPOSE

Provides SPF 15 sun protection.

OTC - WHEN USING

Avoid contact with eyes.

Intrevene Radiance Boosting Moisture Cream Carton

Intervene Radiance Boosting Moisture Cream Bottom Label

INTERVENE RADIANCE BOOSTIN MOISTURE SPF 15
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67938-1044
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (OCTINOXATE)	OCTINOXATE	3.75 g in 50 g
AVOBENZONE (AVOBENZONE)	AVOBENZONE	1.5 g in 50 g
OXYBENZONE (OXYBENZONE)	OXYBENZONE	1.5 g in 50 g

Inactive Ingredients
Ingredient Name	Strength
WATER	21.15 g in 50 g
GLYCERIN	3.18 g in 50 g
BUTYLENE GLYCOL	3.13 g in 50 g
ISONONYL ISONONANOATE	2.12 g in 50 g
DIMETHICONE	1.8 g in 50 g
CETEARYL GLUCOSIDE	1.62 g in 50 g
PENTYLENE GLYCOL	1.5 g in 50 g
BUTYL STEARATE	1.275 g in 50 g
CYCLOMETHICONE 5	0.595 g in 50 g
ETHYLHEXYL PALMITATE	0.476 g in 50 g
ISODODECANE	0.425 g in 50 g
GLYCERYL MONOSTEARATE	0.405 g in 50 g
PEG-100 STEARATE	0.405 g in 50 g
PHENOXYETHANOL	0.25 g in 50 g
MICA	0.14 g in 50 g
POLYETHYLENE GLYCOL 400	0.125 g in 50 g
SODIUM PYRROLIDONE CARBOXYLATE	0.1 g in 50 g
UREA	0.1 g in 50 g
XANTHAN GUM	0.1 g in 50 g
BENZOIC ACID	0.095 g in 50 g
POLYOXYL 60 HYDROGENATED CASTOR OIL	0.075 g in 50 g
NARCISSUS TAZETTA BULB	0.0625 g in 50 g
CHLORPHENESIN	0.061 g in 50 g
PEG-8 LAURATE	0.055 g in 50 g
EDETATE DISODIUM	0.025 g in 50 g
TREHALOSE	0.02 g in 50 g
STEARETH-20	0.015 g in 50 g
SORBIC ACID	0.013 g in 50 g
METHYLPARABEN	0.008 g in 50 g
CAPRYLYL GLYCOL	0.0025 g in 50 g
SODIUM DODECYLBENZENESULFONATE	0.0025 g in 50 g
TRIFOLIUM PRATENSE FLOWER	0.0023 g in 50 g
HYALURONATE SODIUM	0.002 g in 50 g
STANNIC OXIDE	0.00125 g in 50 g
ALPHA-TOCOPHEROL	0.00125 g in 50 g
CHLORHEXIDINE GLUCONATE	0.001 g in 50 g
POTASSIUM SORBATE	0.001 g in 50 g
HEXYLENE GLYCOL	0.00075 g in 50 g
PROPYLPARABEN	0.00055 g in 50 g
PALMITOYL TETRAPEPTIDE-7	0.000225 g in 50 g

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:67938-1044-1	1 JAR (1 JAR) in 1 BOX	contains a JAR (67938-1044-2)
1	NDC:67938-1044-2	50 g in 1 JAR	This package is contained within the BOX (67938-1044-1)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/27/2009

Labeler - Elizabeth Arden, Inc (849222187)

Establishment
Name	Address	ID/FEI	Operations
CEI		032565959	manufacture

Revised: 01/2011 Elizabeth Arden, Inc