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Vaseline Intensive Care Aloe Fresh Protecting Body Lotion

Dosage form: lotion
Ingredients: Octinoxate 7.5mL in 100mL, Oxybenzone 3.0mL in 100mL, Octisalate 1.0mL in 100mL
Labeler: Conopco Inc. d/b/a Unilever
NDC Code: 64942-1048

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 Facts and PDP for Vaseline Intensive Care Aloe Fresh Protecting Body Lotion SPF 15

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 INGREDIENTS:  OCTINOXATE (7.5%)
OXYBENZONE (3.0%)  OCTISALATE (1.0%)

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.

PDP 20.3 oz front

PDP 20.3 oz back

Questions section
VASELINE INTENSIVE CARE  ALOE FRESH PROTECTING BODY LOTION
spf 15 lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1048
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate7.5 mL  in 100 mL
Oxybenzone (Oxybenzone) Oxybenzone3.0 mL  in 100 mL
Octisalate (SALICYLIC ACID) Octisalate1.0 mL  in 100 mL
Packaging
#Item CodePackage Description
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/FEIOperations
Unilever Supply Chain Co. d/b/a Unilever043510056manufacture

Revised: 11/2009
Document Id: 72da477e-c8fa-4656-80e1-1a4234162cdc
Set id: 696246be-8761-48a7-929c-ae412e43762a
Version: 1
Effective Time: 20091104
 
Conopco Inc. d/b/a Unilever

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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