Your browser does not support JavaScript! MEIJER SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [MEIJER DISTRIBUTION INC]
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MEIJER SPF 15 (avobenzone, homosalate, octisalate, octocrylene) lotion
[Meijer Distribution Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredients

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), decrease 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, Fragrance.

Other Information

  •  protect this product from excessive heat and direct sun

Principal Display Panel

meijer

Sunscreen lotion

moisturizing

dermatologist tested

15

Broad Spectrum SPF 15

Water Resistant

(80 Minutes)

10 FL. OZ. (295 mL)


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MEIJER SPF 15 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41250-042
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE2 g  in 100 g
HOMOSALATE (HOMOSALATE) HOMOSALATE10 g  in 100 g
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ETHYLHEXYL PALMITATE 
SORBITOL 
BENZYL ALCOHOL 
DIMETHICONE 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
TROLAMINE 
EDETATE DISODIUM 
TOCOPHEROL 
ALOE VERA LEAF 
CHLORPHENESIN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-042-57286 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/17/2013
Labeler - Meijer Distribution Inc (006959555)

Revised: 7/2013
 
Meijer Distribution Inc

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