Label: MEIJER SPF 4 TANNING OIL- octinoxate, padimate o 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 8, 2013

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  • Active ingredients

    Octinoxate    2.0%

    Padimate O  1.4%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    Skin Cancer Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.

    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.

  • 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
    • children under 6 months of age: ask a doctor
  • Inactive ingredients

    Mineral Oil, Cocos Nucifera (Coconut) Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Zea Mays (Corn) Oil, Musa Sapientum (Banana) Fruit Extract, Retinyl Palmitate, Daucus Carota Sativa (Carrot) Root Extract, Phenoxyethanol, Methylparaben, Isopropylparaben, Butylparaben, Isobutylparaben, Fragrance.


  • 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.
  • Principal Display Panel

    meijer

    Dark Tanning spray oil

    with aloe vera and exotic moisturizers

    4

    spf 4

    Water Resistant

    (80 Minutes)

    Antioxidant Enriched

    8 FL. OZ. (236 mL)


    utntitlded.jpg

  • INGREDIENTS AND APPEARANCE
    MEIJER SPF 4 TANNING OIL 
    octinoxate, padimate o lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-039
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 100 g
    PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O1.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CORN OIL (UNII: 8470G57WFM)  
    BANANA (UNII: 4AJZ4765R9)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CARROT (UNII: L56Z1JK48B)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOPROPYLPARABEN (UNII: A6EOX47QK0)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-039-16226 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/08/2013
    Labeler - Meijer Distribution Inc (006959555)
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