Label: ORALABS CHAPICE CHERRY SPF 4 LIP BALM- padimate o, petrolatum stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 11, 2012

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  • Active ingredient

    Padimate O

    Petrolatum

  • Purpose

    Sunscreen

    Skin Protectant

  • Uses

    Helps prevent sunscreen

  • 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.

    Keep out of reach of children: if swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    Apply liberally before sun exposure and as needed.

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

  • Inactive ingredients

    Mineral oil, Ozokerite, Flavor, Microcrystalline Wax, Isopropyl Myristate, Phenyl Trimethicone, Copernicia Cerifera (Carnauba) Wax, Lanolin, Euphorbia Cerifera (Candellia) Wax, Cetyl Alcohol, Campor, Red 6 Lake (C15850), Methylparaben

  • Package/Label Principal Display Panel

    OraLabs ChapIce Cherry SPF 4 Lip Balm.jpg
  • INGREDIENTS AND APPEARANCE
    ORALABS CHAPICE CHERRY SPF 4 LIP BALM 
    padimate o, petrolatum stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63645-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O15 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM440 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP) 235 mg  in 1 g
    CERESIN (UNII: Q1LS2UJO3A) 175 mg  in 1 g
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) 30 mg  in 1 g
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) 18.5 mg  in 1 g
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 22.3 mg  in 1 g
    CARNAUBA WAX (UNII: R12CBM0EIZ) 10 mg  in 1 g
    LANOLIN (UNII: 7EV65EAW6H) 10 mg  in 1 g
    CANDELILLA WAX (UNII: WL0328HX19) 5 mg  in 1 g
    CETYL ALCOHOL (UNII: 936JST6JCN) 5 mg  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) 2 mg  in 1 g
    METHYLPARABEN (UNII: A2I8C7HI9T) 1 mg  in 1 g
    CHERRY (UNII: BUC5I9595W) 30 mg  in 1 g
    D&C RED NO. 6 (UNII: 481744AI4O) 12 mg  in 1 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63645-111-014.25 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/03/2000
    Labeler - OraLabs (801824756)
    Registrant - OraLabs (801824756)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(63645-111)
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