Label: CHAPSTICK MOISTURIZER- octinoxate, oxybenzone and petrolatum stick 

  • NDC Code(s): 0573-1927-12
  • Packager: Pfizer Consumer Healthcare
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purposes
    Octinoxate 7.5%
    Oxybenzone 3.5% Sunscreens
    White petrolatum 38.7% Skin protectant
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  • Purposes


    Sunscreen

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  • Uses

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

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  • 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
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  • Other information

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

    aloe barbadensis leaf extract, alumina, artificial flavor, blue 1 lake, carnauba wax, cetyl alcohol, ethylhexyl palmitate, isocetyl stearate, isopropyl lanolate, isopropyl myristate, lanolin, medium-chain triglycerides, methylparaben, mineral oil, paraffin, polyhydroxystearic acid, propylparaben, red 6 lake, saccharin, silica, titanium dioxide, vitamin E acetate, white wax

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  • Questions or comments?

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

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

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  • PRINCIPAL DISPLAY PANEL - 4 g Cylinder Blister Pack

    BRAND LIP CARE
    ChapStick®

    SKIN PROTECTANT | SUNSCREEN
    SPF 15

    MOISTURIZER
    RASPBERRY CRÈME

    ULTRA-HYDRATING FORMULA WITH
    10 MOISTURIZERS AND SPF 15

    NET WT 0.15 OZ (4 g)

    Principal Display Panel -  4 g Cylinder Blister Pack
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  • INGREDIENTS AND APPEARANCE
    CHAPSTICK MOISTURIZER 
    octinoxate, oxybenzone, and petrolatum stick
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0573-1927
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg  in 1 g
    OXYBENZONE (OXYBENZONE) OXYBENZONE 35 mg  in 1 g
    PETROLATUM (PETROLATUM) PETROLATUM 387 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    ALUMINUM OXIDE  
    CARNAUBA WAX  
    CETYL ALCOHOL  
    ETHYLHEXYL PALMITATE  
    ISOCETYL STEARATE  
    ISOPROPYL MYRISTATE  
    LANOLIN  
    MEDIUM-CHAIN TRIGLYCERIDES  
    METHYLPARABEN  
    MINERAL OIL  
    PARAFFIN  
    POLYHYDROXYSTEARIC ACID (2300 MW)  
    PROPYLPARABEN  
    SACCHARIN  
    SILICON DIOXIDE  
    TITANIUM DIOXIDE  
    TRIACETIN  
    .ALPHA.-TOCOPHEROL ACETATE  
    WHITE WAX  
    Product Characteristics
    Color      Score     
    Shape BULLET (cylindrical) Size 42mm
    Flavor RASPBERRY (Raspberry Creme) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-1927-12 1 in 1 BLISTER PACK
    1 4 g in 1 CYLINDER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 08/03/2012
    Labeler - Pfizer Consumer Healthcare (828831730)
    Establishment
    Name Address ID/FEI Business Operations
    Fareva Richmond, Inc. 969523245 ANALYSIS(0573-1927), LABEL(0573-1927), MANUFACTURE(0573-1927), PACK(0573-1927), RELABEL(0573-1927), REPACK(0573-1927)
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