Label: RADIABLOCK- oxybenzone and octinoxate lipstick

  • NDC Code(s): 53329-094-83
  • Packager: Medline Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

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

  • Active ingredient

    Oxybenzone 3%

    Padimate O 7%

    Close
  • Purpose

    Sunscreen

    Sunscreen

    Close
  • Uses

    Helps prevent sunburn

    Close
  • 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 help prevent sunburn, not skin cancer or early skin aging.

    For external use only.

    Do not use on damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

    When using this product keep out of eyes. Rinse with water to remove.

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

    Close
  • Directions

    Apply liberally 15 minutes before sun exposure

    Use a water resistant sunscreen if swimming or sweating

    Reaaply at least every 2 hours

    Children under 6 months: Ask a doctor

    Close
  • Principal Display Panel

    SPF 15 Lip Balm

    NDC 53329-094-83

    Carrington

    RadiaBlock

    Sunscreen SPF 15

    Net Wt: .015 oz/4.2g

    C:\Documents and Settings\gateway1\Desktop\53329-094 - Medline - RadiaBlock Lip Sunscreen Principal Display Panel
    Close
  • INGREDIENTS AND APPEARANCE
    RADIABLOCK 
    oxybenzone, octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-094
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 30 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    JOJOBA OIL (UNII: 724GKU717M)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CORN OIL (UNII: 8470G57WFM)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53329-094-83 4.2 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 03/01/2013
    Labeler - Medline Industries, Inc. (025460908)
    Close