Label: KROGER SPORT SPF 50 SUNSTICK- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone stick

  • Category: HUMAN OTC DRUG LABEL

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 April 30, 2013

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  • Active ingredient

    Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone

  • Purpose

    Sunscreen, Sunscreen, Sunscreen, Sunscreen, Sunscreen, Sunscreen,

  • Keep Out of Reach of Children

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • 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.

  • Directions

    Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. immediately after towel drying. at least every two hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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

    BHT, C 12- 15 Alkyl Benzoat, Caprylic/Capric Triglyceride, Ceresin, Flavor, Methylparaben, Propylparaben, PVP/Hexadecene Copolymer, Synthetic Beeswax, Tocopherol, Zinc Oxide.

  • Package/Label Principal Display Panel

    Kroger Sport SPF 50 Front of CardKroger Sport SPF 50 - Back of Card

  • INGREDIENTS AND APPEARANCE
    KROGER SPORT SPF 50 SUNSTICK 
    avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-933
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.00 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.00 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.00 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CERESIN (UNII: Q1LS2UJO3A) 15.00 mg  in 1 g
    WHITE WAX (UNII: 7G1J5DA97F) 14.5 mg  in 1 g
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 10.00 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) 6.00 mg  in 1 g
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) 5.00 mg  in 1 g
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-933-041 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/29/2013
    Labeler - Kroger (006999528)
    Registrant - OraLabs (801824756)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(30142-933) , LABEL(30142-933)
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