MEIJER SPF 30 ULTRA DRY SHEER- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Meijer by

Drug Labeling and Warnings

Meijer by is a Otc medication manufactured, distributed, or labeled by MEIJER DISTRIBUTION, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Meijer SPF 30 Ultra Dry Sheer Lotion - Drug Facts

Active ingredients

Avobenzone 3.0%, Homosalate 8.0%, Octisalate 5.0%, Octocrylene 4.0%, Oxybenzone 4.0%

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 aging caused by the sun

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

ASK DOCTOR

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

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.
• Reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• 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 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-sleeve shirts, pants, hats, and sunglasses

Other information

• protect this product from excessive heat and direct sun
• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

water, silica, dimethicone, potassium cetyl phosphate, beeswax, benzyl alcohol, glyceryl stearate, PEG-100 stearate, cetyl dimethicone, caprylyl methicone, caprylyl glycol, ethyhexylglycerin, dimethicone/PEG-10/15 crosspolymer, sodium polyacrylate, behenyl alcohol, xanthan gum, ethylhexyl stearate, acrylates/C12-22 alkyl methacrylate copolymer, disodium EDTA, chlorphenesin, fragrance, BHT, trideceth-6, propylene glycol

Questions or comments?

Call toll free 1-800-527-7731

PRINCIPAL DISPLAY PANEL

Meijer SPF 30 Ultra Dry Sheer Lotion

3 FL OZ (88mL)

NDC: 41250-984-03

INGREDIENTS AND APPEARANCE

MEIJER  SPF 30 ULTRA DRY SHEER
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-984
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CHLORPHENESIN (UNII: I670DAL4SZ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DOCOSANOL (UNII: 9G1OE216XY)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG-100 STEARATE (UNII: YD01N1999R)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
BENZYL ALCOHOL (UNII: LKG8494WBH)
XANTHAN GUM (UNII: TTV12P4NEE)
CETYL DIMETHICONE 45 (UNII: IK315POC44)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
YELLOW WAX (UNII: 2ZA36H0S2V)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-984-03	88 mL in 1 TUBE; Type 0: Not a Combination Product	08/08/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/08/2019

Labeler - MEIJER DISTRIBUTION, INC (006959555)

Registrant - Fruit Of The Earth, Inc. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(41250-984)