Meijer Oil Free SPF 15

MEIJER OIL FREE SPF 15- avobenzone, homosalate, octisalate and octocrylene lotion
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.

Avobenzone 2.0% Homosalate 10.0% Octisalate 5.0% Octocrylene 5.0%

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. May stain some fabrics.

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
  • 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
  • children under 6 months of age: Ask a doctor

Inactive ingredients

Water, Ethylhexyl Palmitate, Sorbitol, Polyglyceryl-3 Methylglucose Distearate, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Stearate, PEG-100 Stearate, Triethanolamine, Disodium EDTA, Carbomer, Tocopherol, Aloe Barbadensis Leaf Juice Powder, Chlorphenesin.

Other Information

protect this product from excessive heat and direct sun

Principle Display Panel

Meijer Oil Free SPF 15
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MEIJER OIL FREE SPF 15
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:41250-015
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 2 mL in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 10 mL in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 5 mL in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 5 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ETHYLHEXYL PALMITATE
BENZYL ALCOHOL
DIMETHICONE
CARBOMER INTERPOLYMER TYPE A (55000 CPS)
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
TROLAMINE
EDETATE DISODIUM
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
TOCOPHEROL
ALOE VERA LEAF
CHLORPHENESIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41250-015-56 236 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2012
Labeler — Meijer Distribution Inc (006959555)

Revised: 01/2012 Meijer Distribution Inc


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