ULTRASOL SPORT- avobenzone, octinoxate, octisalate, oxybenzone lotion

Ultrasol by

Drug Labeling and Warnings

Ultrasol by is a Otc medication manufactured, distributed, or labeled by Fischer Pharmaceuticals Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients                                                 Purpose
Avobenzone 2.0%, Octinoxate 7.5%,
Octisalate 5.0%, Oxybenzone 4.0% .................. Sunscreen

Uses

helps prevent sunburn higher SPF gives more
sunburn protection helps protect the skin against the
harmful effects of UVA and UVB rays retains SPF after
80 minutes of activity in the water or sweating

Warnings

For external use only

When using this product

avoid contact with the eyes.
If contact occurs rinse thoroughly with water.

Stop use and ask a doctor if

rash or irritation develops
and lasts.

Keep out of reach of children.

If swallowed, get medical
help or contact a Poison Control Center immediately.

Directions

apply generously and evenly to all exposed areas before
sun exposure reapply as needed or after towel drying,
swimming, perspiring or vigorous activity children
under 6 months of age: ask a doctor

Other Information

may stain some fabrics
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.

Inactive Ingredients

Acrylates / C10-30 Alkyl
Acrylate Crosspolymer, Butylparaben, Chlorophenesin,
Disodium EDTA, Ethylparaben, Fragrance, Glyceryl
Stearate, Green Tea (Camellia Sinensis) Leaf Extract,
Iodopropynyl Butylcarbamate, Isopropyl Myristate,
Methylparaben, Phenoxyethanol, Polyethylene,
Potassium Cetyl Phosphate, Propylene Glycol,
Propylparaben, Sodium Hydroxide, Stearic Acid, Stearyl
Alcohol, Tocopheryl Acetate, Water.

Questions or Comments?

Call 1-877-212-1985 Mon-Fri

PRINCIPAL DISPLAY PANEL

Dr. Fischer

ULTRASOL

Sunscreen Lotion SPF45

Broad UVA and UVB protection

Dermatologist Recommended

SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY

VERY WATER RESISTANT

VERY SWEAT RESISTANT

NON GREASY

250 ML. 8.45 FL. OZ.

RECOMMENDED - SKIN CANCER FOUNDATION

FISCHER PHARMACEUTICALS

Manufactured by:

Fischer Pharmaceuticals Ltd.

Bnei Brak, Israel, 51553

Made in Israel

www.dr-fischer.com

NO ANIMAL INGREDIENTS - NO ANIMAL TESTING

24M

Dr. Fischer - Tried and Tested

INGREDIENTS AND APPEARANCE

ULTRASOL  SPORT
avobenzone, octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59886-354
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	2 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Butylparaben (UNII: 3QPI1U3FV8)
Chlorphenesin (UNII: I670DAL4SZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Ethylparaben (UNII: 14255EXE39)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Methylparaben (UNII: A2I8C7HI9T)
Phenoxyethanol (UNII: HIE492ZZ3T)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
Sodium Hydroxide (UNII: 55X04QC32I)
Stearic Acid (UNII: 4ELV7Z65AP)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59886-354-55	250 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/25/2010

Labeler - Fischer Pharmaceuticals Ltd (600158976)

Establishment
Name	Address	ID/FEI	Business Operations
Fischer Pharmaceuticals Ltd		600158976	manufacture