Label: GLOW GO LIP OIL SPF50 (avobenzone 30mg/g, homosalate 100mg/g, octocrylene 100mg/g, octisalate 50mg/g,- sunscreens oil

  • 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 13, 2021

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  • ACTIVE INGREDIENTS

    AVOBENZONE 3 %

    HOMOSALATE 10%

    OCTISALATE 5 %

    OCTOCRYLENE 10%

  • 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.

  • 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 20 minutes before sun exposure

    - Use a water resistant sunscreen if swimming or sweating

    - Re-apply frequently especially after swimming excercising or towel drying

    - Re-apply 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

  • Ingredients

    Candelilla wax, Ethylhexylglycerin, Flavour, Isopropyl myristate, MICA, Octyldodecanol, Phenoxyethanol, Polybutene, Raspberry oil, Tomato extract, Watermelon oil

  • OTHER SAFETY INFORMATION

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

  • Label

    1Label

  • INGREDIENTS AND APPEARANCE
    GLOW GO LIP OIL  SPF50
    avobenzone 30mg/g, homosalate 100mg/g, octocrylene 100mg/g, octisalate 50mg/g, (sunscreens) oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81104-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MICA (UNII: V8A1AW0880)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    TOMATO EXTRACT CONTAINING LYCOPENE (UNII: N53I4V2IA6)  
    WATERMELON SEED OIL (UNII: L33J06UQTT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81104-111-024.5 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2021
    Labeler - NAKED SUNDAY PTY LTD (746918845)
    Establishment
    NameAddressID/FEIBusiness Operations
    WILD CHILD W A PTY LTD744660692manufacture(81104-111) , relabel(81104-111)
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