MEIJER ELEMENTS DAILY FACIAL MOISTURIZER- avobenzone, octocrylene cream 
Meijer Distribution Inc

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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meijer elements® Daily Facial Moisturizer

Active ingredient

Avobenzone 3.0%

Octocrylene 10.0%

Purpose

Sunscreen

Keep Out of Reach of Children

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

Uses

help prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin 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.

Directions

Apply liberally 15 minutes before sun exposure.

Children under 6 months of age: ask a doctor

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 a.m.-2 p.m.

wear long-sleeved shirts, pants, hats and sunglasses

Inactive ingredients

water, diisopropyl adipate, cyclopentasiloxane, glycerin, glyceryl stearate, PEG-100 stearate, titanium dioxide, alumina, simethicone, polymethyl methacrylate, phenoxyethanol, benzyl alcohol, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer, tocopheryl acetate (vitamin E), carbomer, disodium EDTA

Package/Label Principal Display Panel

meijer elements® Daily Facial Moisturizer

Broad Spectrum SPF15 Sunscreen

4 FL OZ (118 mL)

DISTRIBUTED BY:
MEIJER DISTRIBUTION, INC.
2929 WALKER AVE. NW
GRAND RAPIDS,
MI 49544
www.meijer.com
Manufactured in Israel
2T326 6E C1

Meijer Daily Facial Moisturizer Label

Carton Label

 

MEIJER ELEMENTS DAILY FACIAL MOISTURIZER 
avobenzone, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-326
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
PEG-100 STEARATE (UNII: YD01N1999R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW) (UNII: 99Q3C7L77T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-326-261 in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/2012
Labeler - Meijer Distribution Inc (006959555)
Registrant - Zohar Cosmetics (600076624)

Revised: 1/2013
Document Id: 44a71a97-24e7-4118-9df6-7057163c3eca
Set id: 44a71a97-24e7-4118-9df6-7057163c3eca
Version: 1
Effective Time: 20130110
 
Meijer Distribution Inc