INTERVENE RADIANCE BOOSTING MOISTURE SPF 15- octinoxate 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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BB0808

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0808
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 mL  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 mL  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1.5 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67938-0808-11 in 1 BOX
1NDC:67938-0808-250 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/18/2009
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 1/2011
Document Id: 3f4438b9-4b70-4c46-88b0-8daac18d00a4
Set id: c21f6ced-3a9c-4cc8-8e4e-589a08c756c2
Version: 3
Effective Time: 20110113
 
Elizabeth Arden, Inc