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Name:Vaseline Intensive Carealoe Fresh Protecting Body Lotion
Manufacturer:Conopco Inc. D/b/a Unilever
Category:Over-the-counter (OTC) Marketed Drugs


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

VASELINE INTENSIVE CARE ALOE FRESH PROTECTING BODY LOTION - octinoxate, oxybenzone and octisalate lotion 
Conopco Inc. d/b/a Unilever

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.

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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
VIC Aloe SPF front 20pt3oz

PDP 20.3 oz back
VIC Aloe SPF back 20pt3oz

Questions section
VICAloeSPFQuestion/Comments

VASELINE INTENSIVE CARE  ALOE FRESH PROTECTING BODY LOTION
spf 15 lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64942-1048
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 7.5 mL  in 100 mL
Oxybenzone (Oxybenzone) Oxybenzone 3.0 mL  in 100 mL
Octisalate (SALICYLIC ACID) Octisalate 1.0 mL  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64942-1048-1 600 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 12/23/2008

Labeler - Conopco Inc. d/b/a Unilever (001375088)
Establishment
Name Address ID/FEI Operations
Unilever Supply Chain Co. d/b/a Unilever 043510056 manufacture

Revised: 11/2009 Conopco Inc. d/b/a Unilever



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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