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

  • 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

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  • Active Ingredients

    Avobenzone 3%

    Octinoxate 7.5%

    White petrolatum 39.6%

  • Purposes

    Sunscreens

    Skin protectant

  • INDICATIONS & USAGE

    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

    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.

  • DOSAGE & ADMINISTRATION

    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
  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients

    aloe barbadensis leaf extract, artificial flavors, benzyl alcohol, blue 1 lake, carnauba wax, cetyl alcohol, isocetyl stearate, isopropyl lanolate, lanolin, lecithin (soy), medium-chain triglycerides, mineral oil, paraffin, partially hydrogenated vegetable oil, red 40 lake, saccharin, titanium dioxide, tocopheryl linoleate/oleate, vitamin E acetate, white wax, yellow 6 lake, yellow 10 lake

  • QUESTIONS

    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

    Green Apple

    NET WT 0.15 OZ (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Cylinder Blister Pack
  • INGREDIENTS AND APPEARANCE
    CHAPSTICK MOISTURIZER GREEN APPLE 
    avobenzone, octinoxate, and white petrolatum stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0728
    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) PETROLATUM396 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    .ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    SACCHARIN (UNII: FST467XS7D)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Product Characteristics
    ColorGREENScore    
    ShapeBULLETSize42mm
    FlavorAPPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0728-121 in 1 BLISTER PACK06/28/2018
    14 g in 1 CYLINDER; Type 0: Not a Combination Product
    2NDC:0573-0728-403 in 1 BLISTER PACK06/28/2018
    24 g in 1 CYLINDER; Type 0: Not a Combination Product
    3NDC:0573-0728-514 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)
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