MEIJER ELEMENTS LONG-LASTING OIL-FREE- avobenzone, octisalate, octocrylene and oxybenzone cream

Meijer Elements Long-Lasting Oil-Free by

Drug Labeling and Warnings

Meijer Elements Long-Lasting Oil-Free by is a Otc medication manufactured, distributed, or labeled by Meijer Distribution Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Avobenzone 2.0%

Octisalate 5.0%

Octocrylene 4.0%

Oxybenzone 3.0%

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 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.

Keep Out of Reach of Children.

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

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

Other Information

• protect the product in this container from excessive heat and direct sun

Inactive Ingredients

water, carbomer, cetearyl alcohol, ceteareth-20, glycerin, C12-15 alkyl benzoate, glyceryl stearate, PEG-100 stearate, diiosopropyl adipate, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, dimethicone, triethanolamine

Package/Label Principal Display Panel

meijer elements®
Long-Lasting Oil-Free Moisturizer
Broad Spectrum SPF15 Sunscreen

• Hypoallergenic
• Non-comedogenic
• Dermatologist Tested

*Compare to Neutrogena® Oil-Free Moisture SPF15 ingredients

4 fl oz (118 mL)

DIST. BY MEIJER
DISTRIBUTION, INC.
2929 WALKER AVE. NW
GRAND RAPIDS, MI 49544
www.meijer.com
Manufactured in Israel
82026 6E C4

Carton Label

INGREDIENTS AND APPEARANCE

MEIJER ELEMENTS LONG-LASTING OIL-FREE 
avobenzone, octisalate, octocrylene and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-387
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER 1342 (UNII: 809Y72KV36)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-387-73	1 in 1 CARTON
1		118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/11/2012

Labeler - Meijer Distribution Inc. (006959555)