INTERVENE RADIANCE BOOSTING MOISTURE SPF 15- octinoxate lotion

Intervene Radiance Boosting Moisture SPF 15 by

Drug Labeling and Warnings

Intervene Radiance Boosting Moisture SPF 15 by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.75 mL  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 mL  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.5 mL  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
UREA (UNII: 8W8T17847W)
MICA (UNII: V8A1AW0880)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
NARCISSUS TAZETTA BULB (UNII: K17762966S)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
PEG-8 LAURATE (UNII: 762O8IWA10)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
TREHALOSE (UNII: B8WCK70T7I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
STEARETH-20 (UNII: L0Q8IK9E08)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
STANNIC OXIDE (UNII: KM7N50LOS6)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BENZOIC ACID (UNII: 8SKN0B0MIM)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-0808-1	1 in 1 BOX
1	NDC: 67938-0808-2	50 mL in 1 BOTTLE

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)