VASELINE TOTAL MOISTURE ALOE FRESH SPF 15- octisalate, avobenzone, ensulizole lotion

Vaseline by

Drug Labeling and Warnings

Vaseline by is a Otc medication manufactured, distributed, or labeled by CONOPCO Inc. d/b/a Unilever. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose:
Sunscreen

INDICATIONS & USAGE

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

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 INGREDIENT

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.

QUESTIONS

1-800-457-7084

PRINCIPAL DISPLAY PANEL

PDP 20.3 fl. oz.

INGREDIENTS AND APPEARANCE

VASELINE  TOTAL MOISTURE ALOE FRESH SPF 15
octisalate, avobenzone, ensulizole lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64942-1190
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	15 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	13 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64942-1190-1	600 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2012

Labeler - CONOPCO Inc. d/b/a Unilever (001375088)