Label: INTERVENE DAILY MOISTURE SPF 15 OIL FREE- octinoxate and oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated December 27, 2013

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  • 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.

  • PRINCIPAL DISPLAY PANEL

    253605
  • INGREDIENTS AND APPEARANCE
    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)
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