MEIJER - avobenzone, homosalate, octisalate, octocrylene and oxybenzone 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.

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Drug Facts

Active ingredients


Avobenzone     3.0%

Homosalate     15.0%

Octisalate        5.0%

Octocrylene      4.5%

Oxybenzone     6.0%



Purpose

Sunscreen


Uses

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 product is 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, Styrene/Acrylates Copolymer, Butyloctyl Salicylate, Glyceryl Stearate, Silica, PEG-100 Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Methicone, Sodium Polyacrylate, Benzyl Alcohol, Beeswax, Ethylhexyl Stearate, Dimethicone, Cetyl Dimethicone, Xanthan Gum, Trimethylsiloxysilicate, Trideceth-6, Disodium EDTA, Dipotassium Glycyrrhizate, BHT, Chlorphenesin, Fragrance..

Principal Display Panel

meijer

Sheer

Sunscreen lotion

light, clean feel

dermatologist tested

85

Broad Spectrum 85

Water Resistant

(80 Minutes)

3 FL. OZ.

(88 mL)


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Other information

MEIJER 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-035
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41250-035-22 85 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/12/2013
Labeler - Meijer Distribution Inc (006959555)

Revised: 7/2013
Document Id: 499610fd-adb3-411e-92f2-c9596916b50a
Set id: 4183dad4-3ac3-4d9d-86ef-9c5db1529df2
Version: 1
Effective Time: 20130712
 
Meijer Distribution Inc