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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BB0577

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: Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown to prevent sunburnm not skin cancer or early skin aging.  For external us only.

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, SALVIA OFFICINALIS (SAGE) LEAF EXTRACT, HYDROLYZED GLYCOSAMINOGLYCANS, 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, BHT, DISODIUM EDTA, PARFUM/FRAGRANCE, BENZYL SALICYLATE, BUTYLPHENYL METHYLPROPIONAL, CITRONELLOL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, LIMONENE, LINALOOL, DMDM HYDANTOIN, METHYLPARABEN, PHENOXYETHANOL, PROPYLPARABEN.

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure.  Reapply: at least every 2 hours.

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.

253605
INTERVENE DAILY MOISTURE SPF 15 OIL FREE 
octinoxate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0577
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3600 mg  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1800 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
STEARETH-21 (UNII: 53J3F32P58)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PANTHENOL (UNII: WV9CM0O67Z)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
STEARETH-2 (UNII: V56DFE46J5)  
C12-20 ACID PEG-8 ESTER (UNII: 9M7A3K4339)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
RETINYL LINOLEATE (UNII: 61911N8D6W)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67938-0577-11 in 1 BOX
1NDC:67938-0577-250 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/24/2013
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 12/2013
Document Id: 281b08c1-d524-47ba-9635-16ead1dcc9b6
Set id: ad2b1d03-1b68-4312-ab19-0e8eb487a203
Version: 5
Effective Time: 20131227
 
Elizabeth Arden, Inc