Simple Vital Vitamin Day Cream SPF 15

SIMPLE VITAL VITAMIN DAY CREAM SPF 15- homosalate, octisalate, avobenzone, and octocrylene emulsion
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.

----------

Active ingredients
Avobenzone 3.0%
Homosalate 12.0%
Octisalate 5.0%
Octocrylene 2.7%

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions
Apply liberally and evenly to face and neck 15 minutes before sun exposure.
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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
⋅ Limit time in the sun, especially from 10 a.m. - 2 p.m.
⋅ Wear long-sleeved shirts, pants, hats and sunglasses.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
Children under 6 months: Ask a doctor.

Inactive ingredients

Water (Aqua, Eau)

Homosalate

Glycerin

C12-15 Alkyl Benzoate

Ethylhexyl Salicylate

Butyl Methoxydibenzoylmethane

Silica

Octocrylene

Pentylene Glycol

Cetearyl Alcohol

Steareth-21

Steareth-2

Phenoxyethanol

Arachidyl Alcohol

Polyacrylamide

Caprylyl Glycol

Behenyl Alcohol

C13-14 Isoparaffin

Disodium EDTA

Xanthan Gum

Cetearyl Glucoside

Arachidyl Glucoside

Allantoin

Tocopheryl Acetate

Bisabolol

Panthenol

Laureth-7

Triethanolamine

Methylisothiazolinone

Questions or Comments?
1-866-752-4602

PDP front

PDP back

PDP carton

SIMPLE VITAL VITAMIN DAY CREAM SPF 15
homosalate, octisalate, avobenzone, and octocrylene emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64942-1244
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	0.12 g in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.05 g in 1 g
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.03 g in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.027 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
PANTHENOL (UNII: WV9CM0O67Z)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARETH-21 (UNII: 53J3F32P58)
STEARETH-2 (UNII: V56DFE46J5)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DOCOSANOL (UNII: 9G1OE216XY)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ALLANTOIN (UNII: 344S277G0Z)
LEVOMENOL (UNII: 24WE03BX2T)
LAURETH-7 (UNII: Z95S6G8201)
TROLAMINE (UNII: 9O3K93S3TK)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description
Packaging
1	NDC:64942-1244-2	1 in 1 CARTON
1	NDC:64942-1244-1	50 g in 1 JAR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	03/01/2012

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