MOISTURISING SUNSCREEN SPF 30- homosalate, octisalate, octinoxate, octocrylene cream 
Eshu Pty Ltd

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.

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Moisturizing Sunscreen SPF 30+

Active ingredients                   Purpose

Homosalate  8%                   Sunscreen

Octisalate  4%                      Sunscreen

Octinoxate  3%                     Sunscreen

Octocrylene  2%                   Sunscreen

Uses

-Helps prevent sunburn

-higher SPF gives more sunburn protection

-provides high protection against sunburn

-for skin highly sensitive to sunburn

Keep out of reach of children

-Stop use and ask a  doctor if rash or irritation occurs.

-Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce risk 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

warnings

For external use only

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

If swallowed, get medical help or call a poison control center right away


Directions

-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 years of age: ask a doctor.

Inactive ingredients

Allantoin, Ammonium Acryloyldimethicone/VP copolymer, Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetyl Dimethicone, Cylcomethicone, Disodium  EDTA, Ethyl Linoleate, Fragrance, Isostearyl Neopentoate, Lactic Acid, Glycerin, Peg-40 Stearate, Polypropylene, Xanthan gum, Octanohydroxamic acid, Oleyl Alcohol, Panthenol, Panthenyl Triacetate, Pentylene Glycol, Serine, Silica, Sodium chloride, Sodium Lactate, Sorbitol, Tocopherol, Triacontanyl PVP, Urea, water.

image of back label


Moisturizing Sunscreen SPF 30+

100 mL/3.4 oz

Image of front panel



MOISTURISING SUNSCREEN  SPF 30
homosalate, octisalate, octinoxate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42315-672
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
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
LACTIC ACID (UNII: 33X04XA5AT)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
XANTHAN GUM (UNII: TTV12P4NEE)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42315-672-021 in 1 BOX
1NDC:42315-672-01100 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/17/2011
Labeler - Eshu Pty Ltd (753614812)
Registrant - Baxter Laboratories Pty. Ltd. (740537709)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Laboratories Pty. Ltd.740537709manufacture

Revised: 1/2012
Document Id: 76f453cb-70e0-4b82-ae7f-773d45197ed1
Set id: 4b3326a1-b90b-43a4-ba73-c62b3af1f760
Version: 6
Effective Time: 20120105
 
Eshu Pty Ltd