Label: CHAPSTICK MOISTURIZER ORIGINAL- avobenzone, octinoxate, and white petrolatum stick

  • NDC Code(s): 0573-0725-12, 0573-0725-30, 0573-0725-40, 0573-0725-51
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 6, 2020

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

  • Active Ingredients

    Avobenzone 3%

    Octinoxate 7.5%

    White petrolatum 42.3%

    Purposes

    Sunscreens

    Skin protectant

  • 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
    helps prevent and temporarily protects chafed, chapped or cracked lips
    helps prevent and protect from the drying effects of wind and cold weather
  • Warnings

    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.

  • Directions

    apply liberally 15 minutes before sun exposure
    reapply at least every 2 hours
    use a water resistant sunscreen if swimming or sweating
    children under 6 months of age: Ask a doctor
    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    limited time in the sun, especially from 10 a.m. – 2 p.m.
    wear long-sleeved shirts, pants, hats, and sunglasses
  • Other information

    store at 20-25°C (68-77°F)
    protect this product from excessive heat and direct sun
  • Inactive ingredients

    aloe barbadensis leaf extract, carnauba wax, cetyl alcohol, fragrance, isocetyl stearate, isopropyl lanolate, lanolin, mineral oil, paraffin, saccharin, tocopheryl linoleate/oleate, vitamin E acetate, white wax

  • Questions or comments?

    call weekdays from 9 AM to 5 PM EST at 1-877-227-3421

    Additional information

    Marketed by: Pfizer

    Madison, NJ 07940 USA

    ©2018 Pfizer Inc.

    For most recent product information, visit www.chapstick.com

    Paraben Free

  • PRINCIPAL DISPLAY PANEL

    NEW
    Improved
    Formula

    BRAND LIP CARE
    ChapStick®

    SKIN PROTECTANT | SUNSCREEN
    BROAD SPECTRUM SPF 15

    MOISTURIZER
    2 in 1 Lipcare

    8
    HOUR
    MOISTURE

    SPF 15

    Original

    NET WT 0.15 OZ (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Cylinder Blister Pack
  • INGREDIENTS AND APPEARANCE
    CHAPSTICK MOISTURIZER ORIGINAL 
    avobenzone, octinoxate, and white petrolatum stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0725
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM423 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    .ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED)  
    ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    SACCHARIN (UNII: FST467XS7D)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeBULLETSize42mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0725-121 in 1 BLISTER PACK06/28/2018
    14 g in 1 CYLINDER; Type 0: Not a Combination Product
    2NDC:0573-0725-303 in 1 BLISTER PACK06/28/2018
    24 g in 1 CYLINDER; Type 0: Not a Combination Product
    3NDC:0573-0725-403 in 1 BLISTER PACK06/28/2018
    34 g in 1 CYLINDER; Type 0: Not a Combination Product
    4NDC:0573-0725-514 g in 1 CYLINDER; Type 0: Not a Combination Product06/28/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34706/28/2018
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)