Label: ANTIOXIDANT BODY SUNSCREEN CREME SPF50 BROAD SPECTRUM- avobenzone 30mg/g, homosalate 100mg/g, octocrylene 100mg/g, octisalate 50mg/g, oil

  • NDC Code(s): 81104-900-01, 81104-900-02
  • Packager: NAKED SUNDAY PTY LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • 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.

    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

  • 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 15 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:
    Dimethicone, Ethylhexylglycerin, Fragrance, Gluconolactone,
    Glyceryl Monostearate, Kakadu Plum, Phenoxyethanol,
    Potassium Cetyl Phosphate, Purified Water, Sodium
    Benzoate, Sodium Polyacrylate, Tocopherol acetate

  • OTHER SAFETY INFORMATION

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

  • Dosage and Administration

    For External use Only, Apply over skin

  • Label

    12

  • INGREDIENTS AND APPEARANCE
    ANTIOXIDANT BODY SUNSCREEN CREME SPF50 BROAD SPECTRUM 
    avobenzone 30mg/g, homosalate 100mg/g, octocrylene 100mg/g, octisalate 50mg/g, oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81104-900
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81104-900-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2022
    2NDC:81104-900-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/01/2022
    Labeler - NAKED SUNDAY PTY LTD (746918845)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!