Label: MEIJER SUSCREEN SPF 8- octinoxate, 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 July 1, 2013

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  • Active ingredients

    Octinoxate     7.5%

    Oxybenzone   2.0%


  • Uses

    • helps prevent suburn
    • higher SPF gives more sunburn protection
    • retains SPF after 80 minutes of activity in water
  • Warnings

    For external use only


    When using this product

    • keep out of eyes. Rinse with water to remove

    Stop use and ask a doctor if

    • rash or irritation develops and lasts

    Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center right away.


  • Directions

    • apply generously and evenly before sun exposure and as needed
    • children under 6 months of age: ask a doctor
    • reapply frequently and after towel drying, swimming or perspiring
  • Other information

    • may stain some fabrics
    • Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun
  • Inactive ingredients

    Water, Ethylhexyl Palmitate, Propylene Glycol, Cetyl Phosphate, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Tocopherol, Disodium EDTA, Aloe Barbadensis Leaf Juice Powder, Diazolidinyl Urea, Methylparaben, Propylparaben, Fragrance.


  • Principal Display Panel

    meijer

    Sunscreen lotion

    antioxidant enriched

    spf 8

    Moisturizing

    10 FL. OZ. (296 mL)


    untitled.jpg


  • Purpose

    Sunscreen

  • INGREDIENTS AND APPEARANCE
    MEIJER SUSCREEN SPF 8 
    octinoxate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-023-57286 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/01/2013
    Labeler - Meijer Distribution Inc (006959555)
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