Label: ESHU SKIN ASSIST SPF 30- homosalate, octisalate, avobenzone, octocrylene lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 17, 2011

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

View All Sections
  • ACTIVE INGREDIENT

    Homosalate 8%

    Octisalate 4%

    Avobenzone 3%

    Octocrylene 2%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
    • provides high protection against sunburn
    • for skin highly sensitive to sunburn
  • WARNINGS

    For external use only.

  • WHEN USING

    When using this product, keep out of eyes.  Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash or irritation develops and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    • apply liberally and generously onto clean, dry skin and rub in evenly 20 minutes prior to sun exposure
    • apply enough to give a visible layer before rubbing in
    • re-apply as needed every 1-2 hours, or after towel drying, swimming, or perspiring
    • children under 6 months of age: ask a doctor
  • STORAGE AND HANDLING

    • sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun
    • does not provide protection for already burnt skin
    • every case of sunburn damages the skin permanently
    • does not provide 100% protection against UV radiation
    • store in a cool, dry place
    • keep carton.  It contains important information
  • INACTIVE INGREDIENT

    Allantoin, Ammonium Acryloydimethyltaurate/VP Copolymer, Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetyl Dimethicone, Cyclomethicone, Disodium EDTA, Ethyl Linoleate, Fragrance, Isostearyl Neopentanoate, Lactic Acid, Glycerin, PEG-40 Stearate, Polypropylene, Xantham Gum, Octanohydroxamic acid, Oleyl Alcohol, Panthenol, Panthenyl Triacetate, Pentylene Glycol, Serine, Silica, Sodium Chloride, Sodium Lactate, Sorbitol, Tocopherol, Triacontanyl PVP, Urea, Water

  • QUESTIONS

    Questions or Comments? Toll Free 1-855-229-ESHU

    Monday through Friday, 9am-5pm, www.eshu.com.au

  • PRINCIPAL DISPLAY PANEL

    What's in it:

    eshu moisturising sunscreen SPF30+ contains broad spectrum sunscreen filters to help protect the skin and Vitamin E to help moisturise it.  The scent of Eucalyptus, Citrus and Mint leaves you feeling refreshed.

    How to use it:

    Please see the back of our box.  Remember to always take care in the sun.  After all, despite what you may think, your skin is your biggest organ so it deserves the best protection.

    eshu moisturising sunscreen SPF30+ is designed for the Australian climate, the hottest, driest continent on earth, to the strictest of Australian standards.

    And eshu doesn't believe looking after your skin has to be expensive or complicated, so it is reasonably priced and easy to use.  No fuss. No worries. Just smart, effective skin care that works.

    eshu - a new perspective in men's skincare.\

    Eshu Carton

  • INGREDIENTS AND APPEARANCE
    ESHU SKIN ASSIST SPF 30   MOISTURISING SUNSCREEN
    homosalate, octisalate, avobenzone, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42315-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 mL  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mL  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    SERINE (UNII: 452VLY9402)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SORBITOL (UNII: 506T60A25R)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42315-002-34100 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/01/2011
    Labeler - Eshu Pty. Ltd. (753614812)
    Registrant - Eshu Pty. Ltd. (753614812)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Laboratories Pty. Ltd.740537709manufacture
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!