Label: CHAPICE SPF 30 LIP BALM- octinoxate, octocrylene, oxybenzone, octisalate stick

  • Category: HUMAN OTC DRUG LABEL

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 15, 2022

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  • Active ingredient

    Octinoxate (7.5%), Octocrylene (10.0%), Oxybenzone (5.0%), Octisalate (5.0%)

  • Purpose

    Sunscreen, Sunscreen, Sunscreen, Sunscreen

  • Keep Out of Reach of Children

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

  • Uses

    Prevents Sunburns

  • 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

    Mineral Oil, Ozokerite, Petrolatum, Microcrystalline Wax, Ceresin, Flavor, Copernicia Cerifera (Carnauba) Wax, Caprylic/Capric Triglyceride, Titanium Dioxide (CI 77891), Stearic Acid, Tocopheryl Acetate, Aluminum Hydroxide.

  • Package/Label Principal Display Panel

    ChapIce Crazy Flavors SPF 30 Tropical
  • INGREDIENTS AND APPEARANCE
    CHAPICE SPF 30 LIP BALM 
    octinoxate, octocrylene, oxybenzone, octisalate stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63645-164
    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) OXYBENZONE5.0 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10.0 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U) 13.0 mg  in 1 g
    LIGHT MINERAL OIL (UNII: N6K5787QVP) 25.0 mg  in 1 g
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .5 mg  in 1 g
    CERESIN (UNII: Q1LS2UJO3A) 27 mg  in 1 g
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) 4 mg  in 1 g
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorCOCONUTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63645-164-011 g in 1 CONTAINER; Type 0: Not a Combination Product10/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/09/2017
    Labeler - OraLabs (801824756)
    Registrant - OraLabs (801824756)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(63645-164) , LABEL(63645-164)
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