Label: MEIJER CLEAR ZINC SPF 50- octocrylene, zinc oxide 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 12, 2013

If you are a consumer or patient please visit this version.

  • Active ingredients

    Octocrylene    4.0%

    Zinc Oxide      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 Stearate, Diisopropyl Adipate, Cetyl Dimethicone, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Beeswax, Isohexadecane, Sodium Chloride, Hydrogenated Castor Oil, Silica, Triethoxycaprylylsilane, Dimethicone,Tocopherol, Disodium EDTA, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate, Phenoxyethanol, Methylparaben, Propylparaben.

  • Other Information

    •  protect this product from excessive heat and direct sun
  • Principal Display Panel

    meijer

    Clear Zinc

    Sunscreen lotion

    50

    Broad Spectrum SPF 50

    Water Resistant (80 Minutes)

    Goes on Clear Non-Greasy

    Dermatologist Tested UVA/UVB Protection

    FPO

    BLUE CIRCLE REPRESENTS JAR LID

    RED DOTTED LINE REPRESENTS OUTSIDE EDGE OF CLEAR BLISTER

    (DO NOT PRINT)

    NET WT. 1 OZ. (28 g)


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  • INGREDIENTS AND APPEARANCE
    MEIJER CLEAR ZINC SPF 50 
    octocrylene, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-038
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-038-8128 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/12/2013
    Labeler - Meijer Distribution Inc (006959555)