Label: VASELINE INTENSIVE CARE ALOE FRESH PROTECTING BODY LOTION- spf 15 lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 4, 2009

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  • WARNINGS

    WARNING:  FOR EXTERNAL USE ONLY.  AVOID EYE CONTACT.  RINSE WITH WATER TO REMOVE.  IF RASH OR IRRITATION DEVELOPS, STOP USE AND ASK A DOCTOR.  KEEP AWAY FROM CHILDREN.  IF SWALLOWED, CONTACT A POISON CONTROL CENTER RIGHT AWAY.
  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  OCTINOXATE (7.5%)
    OXYBENZONE (3.0%)  OCTISALATE (1.0%)
  • INACTIVE INGREDIENT

    Water, Stearic Acid, Glycerin, Isopropyl
    Palmitate, Aloe Barbadensis (Aloe Vera) Leaf Juice, Euterpe
    Oleracea (Acai) Fruit Extract, Camellia Sinensis (Green Tea)
    Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Tocopheryl
    Acetate, Retinyl Palmitate, Dimethicone, Potassium Lactate,
    Lactic Acid, Collagen Amino Acids, Glycine Soja (Soybean) Sterol,
    Lecithin, Petrolatum, Helianthus Annuus (Sunflower) Seed Oil or
    Glycine Soja (Soybean) Oil, Sodium PCA, Sodium Stearoyl-2-Lactylate,
    Urea, Mineral Water, Glyceryl Stearate, Carbomer, Cetyl Alcohol,
    Magnesium Aluminum Silicate, Fragrance, Potassium Hydroxide,
    DMDM Hydantoin, Disodium EDTA, Methylparaben, Propylparaben,
    Titanium Dioxide.
  • PRINCIPAL DISPLAY PANEL

    PDP 20.3 oz front
    VIC Aloe SPF front 20pt3oz
  • PRINCIPAL DISPLAY PANEL

    PDP 20.3 oz back
    VIC Aloe SPF back 20pt3oz
  • QUESTIONS

    Questions section
    VICAloeSPFQuestion/Comments
  • INGREDIENTS AND APPEARANCE
    VASELINE INTENSIVE CARE  ALOE FRESH PROTECTING BODY LOTION
    spf 15 lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1048
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 mL  in 100 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone3.0 mL  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (SALICYLIC ACID - UNII:O414PZ4LPZ) Octisalate1.0 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1048-1600 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/23/2008
    Labeler - Conopco Inc. d/b/a Unilever (001375088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unilever Supply Chain Co. d/b/a Unilever043510056manufacture
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