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

Eshu Skin Assist SPF 30 by

Drug Labeling and Warnings

Eshu Skin Assist SPF 30 by is a Otc medication manufactured, distributed, or labeled by Eshu Pty. Ltd., Baxter Laboratories Pty. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.\

INGREDIENTS AND APPEARANCE

ESHU SKIN ASSIST SPF 30   MOISTURISING SUNSCREEN
homosalate, octisalate, avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42315-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42315-002-34	100 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2011

Labeler - Eshu Pty. Ltd. (753614812)

Registrant - Eshu Pty. Ltd. (753614812)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Laboratories Pty. Ltd.		740537709	manufacture