Label: RITE AID ESSENTIAL DEFENSE SPF 45- avobenzone homosalate octisalate octocrylene 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 November 21, 2012

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  • Active Ingredients

    Avobenzone 2.0 %

    Homosalate 12.0%

    Octinoxate 7.5%

    Octisalate 5.0%

    Oxybenzone 6.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
    • retains SPF after 80 minutes of activity in the water
  • Warnings

    For external use only

    When using this product

    • keep out of eyes. Rinse with water to remove.

    stop use and ask a doctor if

    • rash or irritation develops and lasts

    Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control Center right away.

    Other Information

    • may stain some materials
  • Directions

    • shake well
    • apply generously before sun exposure and as needed
    • children under 6 months of age:ask a doctor
    • reapply frequently and after towel drying, swimming or perspiring.
  • Inactive Ingredients

    Water, Methylpropanediol, VP/Eicosene Copolymer, Sorbitan Isostearate, Cetyl Alcohol, Triethanolamine, Isostearic Acid, Stearic Acid, Cetyl Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Methylparaben, Chlorphenesin, Fragrance, Benzoic Acid, Phenoxyethanol, Disodium EDTA, Bisabolol, Retinyl Palmitate, Ascorbic Acid, Tocopheryl Acetate, PEG-8 Dimethicone, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Octyldodecanol, Silica.
  • Principal Display Panel

    RITE
    AID
    Essential Defence
    OIL FREE SUNSCREEN LOTION
    SPF
    45
    Broad Spectrum Protection
    RECOMMENDED
    SKIN CANCER
    FOUNDATION
    won't clog pores
    very water resistance
    Vitamins A, C and E
    4 FL. OZ. (118 mL)
    ZRA012A0.jpg
  • INGREDIENTS AND APPEARANCE
    RITE AID ESSENTIAL DEFENSE  SPF 45
    avobenzone homosalate octisalate octocrylene oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-9004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE12 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-9004-3113 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/21/2012
    Labeler - RITE AID CORPORATION (014578892)
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