Label: CLEAR GLOW RADIANT SUN SERUM SPF50 (avobenzone 15mg/g, homosalate 5mg/g, octocrylene 25mg/g,- sunscreen lotion

  • NDC Code(s): 81104-112-01, 81104-112-02
  • Packager: NAKED SUNDAYS PTY LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2023

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  • ACTIVE INGREDIENTS

    AVOBENZONE 3 %

    HOMOSALATE 10%

    OCTISALATE 5 %

  • 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

    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 help prevent sunburn, not skin cancer or early skin aging

    - 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 15 minutes before sun exposure

    - reapply after 80 minutes of swimming or sweating

    - Re-apply immedieatly after 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

    caprylyl carbonate,caprylyl Methicone, Citrullus Lanatus Seed Oil, Cyclomethicone,Dimethicone crosspolymer, PEG-12 demithicone/PPG-20 Crosspolymer, Phenyl Trimethicone, Silica Silylate, Simmondsia chinensis ( jojoba) seed oil, Solanum Lycopersicum ( tomato)fruit extract,Squalane, terminalia ferdinadiana oil

  • OTHER SAFETY INFORMATION

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

  • DOSAGE & ADMINISTRATION

    Apply 15 minutes before skin exposure

  • Label

    12

  • INGREDIENTS AND APPEARANCE
    CLEAR GLOW RADIANT SUN SERUM  SPF50
    avobenzone 15mg/g, homosalate 5mg/g, octocrylene 25mg/g, (sunscreen) lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81104-112
    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
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    SQUALANE (UNII: GW89575KF9)  
    KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
    TOMATO JUICE (UNII: U4475AYH9C)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    WATERMELON SEED OIL (UNII: L33J06UQTT)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81104-112-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product01/31/2022
    2NDC:81104-112-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product01/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/31/2022
    Labeler - NAKED SUNDAYS PTY LTD (746918845)
    Registrant - WILD CHILD WA PTY LTD (746918845)
    Establishment
    NameAddressID/FEIBusiness Operations
    WILD CHILD WA PTY LTD744660692manufacture(81104-112)
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