Label: RITE AID DARK TANNING SPF 4- 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

    Octocrylene 1.0%
    Oxybenzone 0.5 %
  • 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 the reach of children.

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

  • Directions

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

    • may stain some materials
  • Inactive ingredients

    Water, Petrolatum, Diisopropyl Adipate, Propylene Glycol, Polyglyceryl-3 Methylglucose Distearate, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Benzyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea) Butter, Disodium EDTA, Aloe Barbadensis Leaf Juice Powder, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Methylparaben, Propylparaben, Quaternium-15, Fragrance.
  • Principal Display Panel

    RITE
    AID
    DARK
    TANNING
    LOTION
    SPF
    4
    Aloe vera Gel
    Very Water Resistant
    Vitamins A, C and E
    8 FL OZ (237 mL)
    Z90494A0.jpg
  • INGREDIENTS AND APPEARANCE
    RITE AID DARK TANNING  SPF 4
    octocrylene oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-9006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    QUATERNIUM-15 (UNII: E40U03LEM0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-9006-6226 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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