Label: CHERRY CANDY CANE LIP BALM- octinoxate, oxybenzone, octisalate lipstick

  • 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 September 16, 2009

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  • ACTIVE INGREDIENT

    Active ingredients                                              Purpose
    Octyl Methoxycinnamate 7.5 percent                   Sunscreen
    Oxybenzone 3.0 percent                                     Sunscreen
    Octyl Salicylate 2.0 percent                                 Sunscreen
  • PURPOSE

    Uses    
    - Helps prevent sunburn
    - Higher SPF gives more sunburn protection
    - Helps prevent and temporarily protects dry, chapped or windburned lips
  • ASK DOCTOR

    Stop use and ask a doctor if
    - rash or irritation develops and lasts
    - condition worsens or does not improve within 7 days
  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions
    - Apply liberally before sun exposure and as needed
    - Children under 6 months of age, ask a doctor
  • INFORMATION FOR PATIENTS

    Other Information
    Sun alert. Limiting sun exposure, wearing protective
    clothing, and using sunscreens may reduce the risks
    of skin aging, skin cancer, and other harmful effects
    of the sun.
  • INACTIVE INGREDIENT

    Inactive Ingredients
    POLYBUTENE, MINERAL OIL, ETHYLHEXYL PALMITATE,
    PARAFFIN, CERESINE, MICROCRYSTALLINE WAX, BEES
    WAX, FRAGRANCE, METHYLPARABEN, PROPYLPARABEN,
    D AND C RED NO. 6 BA LAKE, D AND C RED NO. 27 AL LAKE,
    TITANIUM DIOXIDE


  • QUESTIONS

    For Add'l Info Call:
    1.800.999.9322 or Visit
    hiyamints.com or
    webbcandy.com
  • PRINCIPAL DISPLAY PANEL

    Webb Candy Cherry Lip Balm
  • INGREDIENTS AND APPEARANCE
    CHERRY CANDY CANE LIP BALM 
    octinoxate, oxybenzone, octisalate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49701-9001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    WAX, YELLOW (UNII: 2ZA36H0S2V)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49701-9001-1425 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/11/2009
    Labeler - Webb Candy (785835294)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jinhua Garland Cosmetic Co., Ltd546371824manufacture
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