ULTRASOL SUNSCREEN LOTION SPF 45- avobenzone, octinoxate, octisalate, oxyybenzone 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

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

Section Text
Dr. Fischer ULTRASOL
Sunscreen Lotion SPF 45
Broad Spectrum
UVA and UVB Protection
Dermatologist Recommended
Science InsideTM  Superior Sun Technology
Very Water Resistant
Hypoallergenic
Sensitive Approved
Recommended - Skin Cancer Foundation
125 ML. 4.22 FL. OZ.
FISCHER PHARMACEUTICALS
(Back of Package):
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  SUNSCREEN LOTION SPF 45
avobenzone, octinoxate, octisalate, oxyybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59886-355
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: 59886-355-11	125 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2010

Labeler - Fischer Pharmaceuticals Ltd. (600158976)

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