Label: SHOPKO CHERRY SPF 4 LIP BALM- padimate o, petrolatum stick

  • 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 23, 2013

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

View All Sections
  • Active ingredient

    Padimate O, Petrolatum

  • Purpose

    Sunscreen, Skin Protectant

  • Keep Out of Reach of Children

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

  • Uses

    Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.

  • 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

    Stop use and ask a doctor: If rash or irritation develops and lasts.

  • Directions

    Apply liberally before sun exposure and as needed.

    Children under 6 months of age: Ask a doctor before use.

  • Inactive Ingredients

    Mineral Oil, Ozokerite, Flavor, Microcrystalline Wax, Isopropyl Myristate, Phenyl Trimethicone, Copernicia Cerifera (Carnauba) Wax, Lanolin, Euphorbia Cerifera (Candelilla) Wax, Cetyl Alcohol, Camphor, Red 6 Lake (CI 15850), Methylparaben

  • Package/Label Principal Display Panel

    Shopko Front and Back Card SPF 4 Cherry Lip Balm
  • INGREDIENTS AND APPEARANCE
    SHOPKO CHERRY SPF 4 LIP BALM 
    padimate o, petrolatum stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-731
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM44.0 mg  in 1 g
    PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP) 23.50 mg  in 1 g
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) 3.00 mg  in 1 g
    LANOLIN (UNII: 7EV65EAW6H) 1 mg  in 1 g
    CERESIN (UNII: Q1LS2UJO3A) 17.50 mg  in 1 g
    CARNAUBA WAX (UNII: R12CBM0EIZ) 1 mg  in 1 g
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 2.23 mg  in 1 g
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-731-021 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/15/2013
    Labeler - Shopko (023252638)
    Registrant - Shopko (023252638)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(37012-731) , LABEL(37012-731)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!