Label: KROGER DARK TANNING OIL SPF 4- octinoxate spray

  • 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 November 19, 2012

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  • Active ingredient

    Octinoxate 3.0%
  • Purpose

    Sunscreen

  • Uses

    • minimal sun protection
    • higher SPF gives more sunburn protection
    • to be used by those with a base tan
  • 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

    • do not spray directly on face
    • apply generously and evenly before sun exposure and as needed
    • reapply frequently and after towel drying, swimming or perspiring.
    • this product is not recommended for use on children
  • Inactive ingredients

    Mineral Oil, Isopropyl Myristate, Sesamum Indicum (Sesame) Seed Oil, Persea Gratissima (Avocado) Oil, Amyl Acetate, Cocos Nucifera (Coconut) Oil, Squalane, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Aleurites Moluccana Seed Extract, Carica Papaya (Papaya) Fruit Extract, Colocasia Antiquorum Root Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Eucalyptus Globulus Leaf Oil, Fragrance.
  • Principal Display Panel

    kroger
    QUALITY GUARANTEED
    Dark Tanning
    4 spf
    SPRAY OIL
    Antioxidant
    Enriched
    8 FL OZ(236 mL)
    ZKR020A0.jpg
  • INGREDIENTS AND APPEARANCE
    KROGER DARK TANNING OIL  SPF 4
    octinoxate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-904
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    AMYL ACETATE (UNII: 92Q24NH7AS)  
    PAPAYA (UNII: KU94FIY6JB)  
    COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)  
    GUAVA (UNII: 74O70D6VG0)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    MANGO (UNII: I629I3NR86)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-904-16226 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/19/2012
    Labeler - THE KROGER CO (006999528)
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