MOISTURISING SUNSCREEN SPF 30- homosalate, octisalate, octinoxate, octocrylene cream

moisturising sunscreen by

Drug Labeling and Warnings

moisturising sunscreen 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

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.

PRINCIPAL DISPLAY PANEL

Moisturizing Sunscreen SPF 30+

100 mL/3.4 oz

INGREDIENTS AND APPEARANCE

MOISTURISING SUNSCREEN  SPF 30
homosalate, octisalate, octinoxate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42315-672
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
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42315-672-02	1 in 1 BOX
1	NDC: 42315-672-01	100 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/17/2011

Labeler - Eshu Pty Ltd (753614812)

Registrant - Baxter Laboratories Pty. Ltd. (740537709)

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