Label: SPF50 SHEER GLOW BALM TRIO- zinc oxide 22.75% lipstick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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  • ACTIVE INGREDIENTS

    ZINC OXIDE 22.75 %

  • PURPOSE

    SUNSCREEN

  • USE

    - Helps prevents sunburn

    - If used as directed with other sun protection measures ( see directions) decreases the risk of skin cancer and early skin ageing caused by the sun.

  • WARNINGS

    FOR EXTERNAL USE ONLY

    - Do not use on damaged or broken skin.

    Skin Cancer/Skin Aging Alert: Spending time in the sun
    increases your risk of skin cancer and early skin aging.
    To decrease this risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measure including - Limit time in the sun especially from 10:00 AM to 2: 00 PM , Wear Long Slleve Shirts, pants hats and Sunglasses.

  • WHEN USING

    keep out of eyes, Rinse with water to remove

  • Stop use & ask doctor

    If rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    If product is swallowed , get medical help or contact a poison control center right away

  • Directions

    Apply generously 20 minutes before sun exposure.
    Use a water-resistant sunscreen if swimming or sweating.
    Reapply immediately after towel drying.
    Reapply at least every 2 hours.
    Children under 6 months of age: Ask a doctor.

  • Sun Protection Measures :

    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad spectrum SPF value of 15 or higher and other sun protection measures inclusing:

    - limit time in the sun, especially from 10:00 AM- 02:00 PM

    - Wear long- Sleeved shirts , pants, Hats and sunglasses

  • Inactive Ingredients

    Inactive Ingredients:
    C12- C15 Alkyl Benzoate, Candelilla Wax, Carnauba Wax, Castor Oil. Coco Caprylate/Caprate, Dl-alpha-tocopheryl Acetate, Isostearic Acid, Mica, Ozokerite, Polyglyceryl-3 Polyglyceryl-3 Polyricinoleate, Theobroma Cacao ( Cocoa) Seed Butter

  • OTHER SAFETY INFORMATION

    Protect the product in this container from excessive heat & direct sun

  • DOSAGE & ADMINISTRATION

    For External use only

  • Label

    1234

  • INGREDIENTS AND APPEARANCE
    SPF50 SHEER GLOW BALM TRIO 
    zinc oxide 22.75% lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81104-899
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE22.75 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    CERESIN (UNII: Q1LS2UJO3A)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    MICA (UNII: V8A1AW0880)  
    THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81104-899-0110 g in 1 KIT; Type 0: Not a Combination Product12/26/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/26/2022
    Labeler - NAKED SUNDAY PTY LTD (746918845)
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