Label: MEIJER OIL FREE FACES SPF 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated May 25, 2016

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  • Active Ingredients

    AVOBENZONE 2.0%, HOMOSALATE 13.0%, OCTISALATE 5.0%, OCTOCRYLENE 2.0%, 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 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 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 lease 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. to 2 p.m.
    • wear long-sleeve shrits, pants, hats, and sunglasses
    • children under 6 months of age: Ask a doctor
  • Inactive Ingredients

    Water, Sorbitol, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Palmitic Acid, Sorbitan Isostearate, Stearic Acid, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben,

    Propylparaben.

  • Other information

    • protect this product from excessive heat and direct sun
  • Principle Display Label

    41250-438-22

    meijer

    Oil Free

    Sunscreen Lotion

    Faces

    hypoallergenic

    no added fragrance

    30

    Broad Spectrum

    SPF 30

    Water Resistant

    (80 minutes)

    3 Fl. Oz. (88mL)

    Label

  • INGREDIENTS AND APPEARANCE
    MEIJER OIL FREE FACES SPF 30 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-438
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE13 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    Tocopherol (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-438-2288 g in 1 BOTTLE; Type 0: Not a Combination Product05/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/25/2016
    Labeler - Meijer (006959555)
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