VASELINE TOTAL MOISTURE ALOE FRESH SPF 15- octisalate, avobenzone, ensulizole 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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Vaseline Total Moisture Aloe Fresh SPF 15

Active Ingredients
Avobenzone (2.0%), Ensulizole (1.5%), Octisalate (5.0%), Octocrylene (1.3%)

Purpose:
Sunscreen

Uses
∙ helps prevent sunburn
∙ if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.

Warnings
For external use only

Do not use ∙ on damaged or broken skin

When using this product ∙ keep out of eyes ∙ rinse with water to remove

Stop Use and ask a doctor if · rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

∙ apply generously and evenly 15 minutes before sun exposure.

∙ children under 6 months of age: Ask a doctor

∙ reapply at least every two hours

∙ use a water resistant sunscreen if swimming or sweating

Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

∙ Limit time in the sun, especially from 10 am - 2 pm

∙ Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients
Water (Aqua), Glycerin, Stearic Acid, Glycol Stearate, PEG-100 Stearate, Dimethicone, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Dihydroxypropyltrimonium Chloride,Tocopheryl Acetate, Phenoxyethanol, Glyceryl Stearate, Potassium Stearate, Carbomer, Cetyl Alcohol, Caprylyl Glycol, Xanthan Gum,Fragrance (Parfum), Disodium EDTA, BHT, Stearamide AMP, Methylisothiazolinone.

1-800-457-7084

PDP 20.3 fl. oz.

Vaseline Total Moisture Aloe SPF 15 PDP
VASELINE  TOTAL MOISTURE ALOE FRESH SPF 15
octisalate, avobenzone, ensulizole lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1190
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE15 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE13 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
PEG-100 STEARATE (UNII: YD01N1999R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIHYDROXYPROPYLTRIMONIUM CHLORIDE (UNII: V5RP514IX5)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STEARAMIDE AMP (UNII: U3K8640346)  
POTASSIUM STEARATE (UNII: 17V812XK50)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64942-1190-1600 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2012
Labeler - CONOPCO Inc. d/b/a Unilever (001375088)

Revised: 10/2012
Document Id: d34e43e6-8cf8-44dc-a4fe-04cc709dcbaa
Set id: 74629662-edac-4206-a543-0e67a5da2621
Version: 1
Effective Time: 20121011
 
CONOPCO Inc. d/b/a Unilever