INTERVENE RADIANCE BOOSTING MOISTURE SPF 15 - octinoxate, avobenzone 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 multi-benefit moisturizer immediately boosts skin's appearance for a radiant, clear, 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 minimze 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

Warnings: 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 7.5% w/w, Avobenzone 3.0% w/w, Oxybenzone 3.0% w/w.

INACTIVE INGREDIENT

Other Ingredients: Water/Aqua/Eau, Ethylhexyl Methoxycinnamite, C12-15 Alkyl Benzoate, Glycerin, Ceteareth-6 Olivate, Butylene Glycol, Benzophenone-3, Butyl Methoxydibenzoylmethane, Pentylene Glycol, Tridecyl Salicylate, Caprylice/Capric Triglyceride, PEG-11 Methyl Ehter Dimethcone, Dimethicone, Narcissus Tazetta Bulb Extract, Trifolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Tocopherol, Tocopheryl Acetate, Caprylyl Methicone, Caprylyl Glycol, Ethylhexyl Palmitate, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, Sodium PCA, Trehalose, Urea, Hydrolyzed Soy Protein, Lecithin, Palmitoyl Tetrapeptide-7, PEG/PPG-18/18 Dimethicone, PEG-8 Laurate, Steareth-20, Trideceth-6, Trideceth-9, Sodium Dodecylbenzenesulfonate, Polyquaternium-51, Styrene/Acrylates Copolymer, Hexylene Glycol, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Hydroxyethylcellulose, Sodium Polyacrylate, Xanthan Gum, Nylon-12, Triethanolamine, Disodium EDTA, Mica, Tin Oxide, Cyclopentasiloxane, Silica, Dimethyl Silylate, Parfum/Fragrance, Butylphenyl Methylpropional, Citronellol, Limonene, Linalool, Benzoic Acid, Methylparaben, Phenoxyethanol, Potassium Sorbate, Chlorhexidine Digluconate, Chlorphenesin, O-Cymen-5-ol, Titanium Dioxide (CI77891).

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.

Intervene Radiance Boosting Moisture Lotion Carton

Intervene Radiance Boosting Moisture Lotion Bottle

INTERVENE RADIANCE BOOSTING MOISTURE SPF 15
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67938-0808
Route of Administration	TOPICAL	DEA Schedule

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

Inactive Ingredients
Ingredient Name	Strength
WATER	25.262 mL in 50 mL
ALKYL (C12-15) BENZOATE	2.5 mL in 50 mL
GLYCERIN	2.409 mL in 50 mL
PENTYLENE GLYCOL	1.5 mL in 50 mL
MEDIUM-CHAIN TRIGLYCERIDES	1 mL in 50 mL
DIMETHICONE	0.69 mL in 50 mL
ETHYLHEXYL PALMITATE	0.476 mL in 50 mL
PHENOXYETHANOL	0.261 mL in 50 mL
TROLAMINE	0.175 mL in 50 mL
SODIUM PYRROLIDONE CARBOXYLATE	0.15 mL in 50 mL
UREA	0.15 mL in 50 mL
MICA	0.14 mL in 50 mL
POLYOXYL 40 HYDROGENATED CASTOR OIL	0.125 mL in 50 mL
CYCLOMETHICONE 5	0.09 mL in 50 mL
NARCISSUS TAZETTA BULB	0.0625 mL in 50 mL
TRIDECETH-6	0.06 mL in 50 mL
PEG-8 LAURATE	0.055 mL in 50 mL
O-CYMEN-5-OL	0.045 mL in 50 mL
TREHALOSE	0.03 mL in 50 mL
EDETATE DISODIUM	0.025 mL in 50 mL
XANTHAN GUM	0.025 mL in 50 mL
STEARETH-20	0.015 mL in 50 mL
PROPYLENE GLYCOL	0.0125 mL in 50 mL
METHYLPARABEN	0.00314 mL in 50 mL
CAPRYLYL GLYCOL	0.0025 mL in 50 mL
SODIUM DODECYLBENZENESULFONATE	0.0025 mL in 50 mL
HYALURONATE SODIUM	0.0025 mL in 50 mL
CHLORPHENESIN	0.0024 mL in 50 mL
TRIFOLIUM PRATENSE FLOWER	0.0022 mL in 50 mL
STANNIC OXIDE	0.0012 mL in 50 mL
ALPHA-TOCOPHEROL	0.0012 mL in 50 mL
CHLORHEXIDINE GLUCONATE	0.001 mL in 50 mL
POTASSIUM SORBATE	0.001 mL in 50 mL
BENZOIC ACID	0.0009 mL in 50 mL
HEXYLENE GLYCOL	0.00075 mL in 50 mL
PALMITOYL TETRAPEPTIDE-7	0.00022 mL in 50 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:67938-0808-1	1 BOTTLE (1 BOTTLE) in 1 BOX	contains a BOTTLE (67938-0808-2)
1	NDC:67938-0808-2	50 mL in 1 BOTTLE	This package is contained within the BOX (67938-0808-1)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/18/2009

Labeler - Elizabeth Arden, Inc (849222187)

Establishment
Name	Address	ID/FEI	Operations
CEI		032565959	manufacture

Revised: 01/2011 Elizabeth Arden, Inc