CVS HEALTH ORIGINAL SPF 15 LIP BALM (OXYBENZONE, OCTINOXATE, PETROLATUM) STICK [CVS]

CVS HEALTH ORIGINAL SPF 15 LIP BALM (OXYBENZONE, OCTINOXATE, PETROLATUM) STICK [CVS]
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NDC 69842-552-02
Set ID 6d58a18c-62ba-4cee-b3cc-51db746ba50e
Category HUMAN OTC DRUG LABEL
Packager CVS
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredient

    Octinoxate (7.5%), Oxybenzone (3.5%)

    Petrolatum (44.0%)

  • Purpose

    Sunscreen, Sunscreen, Skin Protectant

  • Keep Out of Reach of Children

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

  • Uses

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

  • 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.

  • Directions

    Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

  • Inactive Ingredients

    Camphor, Cetyl Alcohol, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Flavor, Isopropyl Myristate, Lanolin, Microcrystalline Wax, Mineral Oil, Ozokerite, Phenyl Trimethicone, Red 6 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140)..

  • Package/Label Principal Display Panel

    CVS Health Extended Length Label
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH ORIGINAL SPF 15 LIP BALM 
    oxybenzone, octinoxate, petrolatum stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-552
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.5 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM44.0 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP) 18.00 mg  in 1 g
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) 3.00 mg  in 1 g
    LANOLIN (UNII: 7EV65EAW6H) 1 mg  in 1 g
    CERESIN (UNII: Q1LS2UJO3A) 17.3 mg  in 1 g
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) .900 mg  in 1 g
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-552-021 g in 1 CONTAINER; Type 0: Not a Combination Product08/17/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/17/2015
    Labeler - CVS (062312574)
    Registrant - OraLabs (801824756)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(69842-552) , LABEL(69842-552)

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