Label: CAO COSMETIC LIP SUNSCREEN SPF 30- avobenzone, octocrylene ointment

  • NDC Code(s): 82564-000-01
  • Packager: S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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  • Drug Facts

  • Active ingredients

    Avobenzone 2.8%

    Octocrylene 5%

    Purpose

    Sunscreen

  • Use

    • helps prevent sunburn
  • Warnings

    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. Skin Cancer/Skin Aging Alert:For external use only

    Do not use

    • on damaged or broken skin

    When using this product

    • keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    • rash occurs

    Keep out of reach of children.

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

  • 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
  • Other Information

    • protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    diisostearyl malate, hydrogenated polyisobutene, bis-diglyceryl polyacyladipate-2, isopropyl myristate, microcrystalline wax, shea  (Butyrospermum parkii) butter, isoamyl p-methoxycinnamate, silica, polyglyceryl-3 diisostearate, tocopheryl acetate, fragrance (parfum), argan tree (Argania spinosa) kernel oil, coconut (Cocos nucifera) oil, water (aqua), butylene glycol, peach (Prunus persica) leaf extract, benzyl benzoate.

  • Package Labeling:

    UpdatedLabel

  • INGREDIENTS AND APPEARANCE
    CAO COSMETIC LIP SUNSCREEN SPF 30 
    avobenzone, octocrylene ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82564-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    AMILOXATE (UNII: 376KTP06K8)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PRUNUS PERSICA LEAF (UNII: VN3501T41P)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82564-000-011 in 1 CARTON10/01/2022
    16 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/01/2022
    Labeler - S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED (660783924)
    Establishment
    NameAddressID/FEIBusiness Operations
    S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED660783924manufacture(82564-000)
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