Label: RADIABLOCK- oxybenzone, octinoxate lipstick

  • NDC Code(s): 53329-094-83
  • Packager: Medline Industries, LP
  • 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 August 17, 2023

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

  • Active ingredient

    Oxybenzone 3%

    Padimate O 7%

  • Purpose

    Sunscreen

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

    For external use only.

    Do not use

    on broken or damaged 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.

  • 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

  • Inactive ingredients

    Aloe Barbadensis (Aloe Vera) Leaf Extract, Copernicia Cerifera (Carnauba) Wax, Flavor, Mineral Oil, Paraffin, Petrolatum, Retinyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol (Vitamin E), Zea Mays (Corn) Oil (and) BHA (and) Propyl Gallate (and) Citric Acid

  • Other information

    • protect the product in this container from excessive heat and direct sun
    • do not use if safety seal is broken or missing
  • Questions or comments?

    1-800-MEDLINE (633-5463)

    Monday-Friday, 9AM-5PM CST

  • 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
  • INGREDIENTS AND APPEARANCE
    RADIABLOCK 
    oxybenzone, octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-094
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CORN OIL (UNII: 8470G57WFM)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-094-834.2 g in 1 TUBE; Type 0: Not a Combination Product03/01/201304/30/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/201304/30/2025
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)