Label: CARE ONE CHERRY SPF 4 LIP BALM- petrolatum and padimate o stick 

  • Label RSS
  • NDC Code(s): 41520-978-02
  • Packager: American Sales Company
  • 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 03/13

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  • Active ingredient

    Padimate O, White Petrolatum

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  • Purpose

    Sunscreen, Skin Protectant

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  • Keep Out of Reach of Children

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

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  • Uses

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

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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 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.

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  • Directions

    Apply liberally before sun exposure and as needed.

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

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  • 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

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  • Package/Label Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    CARE ONE CHERRY SPF 4 LIP BALM 
    padimate o, petrolatum stick
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-978
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PETROLATUM (PETROLATUM) PETROLATUM 44.0 mg  in 1 g
    PADIMATE O (PADIMATE O) PADIMATE O 1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    LIGHT MINERAL OIL 23.50 mg  in 1 g
    MICROCRYSTALLINE WAX 3.00 mg  in 1 g
    LANOLIN 1 mg  in 1 g
    CERESIN 17.50 mg  in 1 g
    CARNAUBA WAX 1 mg  in 1 g
    ISOPROPYL MYRISTATE 2.23 mg  in 1 g
    Product Characteristics
    Color PINK Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-978-02 1 g in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 03/15/2013
    Labeler - American Sales Company (809183973)
    Registrant - American Sales Company (809183973)
    Establishment
    Name Address ID/FEI Business Operations
    OraLabs 801824756 MANUFACTURE(41520-978), LABEL(41520-978)
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