ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34- avobenzone, octinoxate, octisalate, oxybenzone lotion

UltrasolSunscreen by

Drug Labeling and Warnings

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

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

Dr. Fischer ULTRASOL

Sunscreen Lotion

SPF34

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

Drug Facts

Active Ingredients                                                                                 Purpose
Avobenzone 2.0%, Octinoxate 7.5%, Octisalate 3.0%,
Oxybenzone 3.0% ........................................................................... Sunscreen

Uses

helps prevent sunburn higher SPF gives more sunburn protection
helps protect the skin against the h armful 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 u s e 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 sun screens may reduce th e
risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredients

Acrylates / C 10-30 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

INGREDIENTS AND APPEARANCE

ULTRASOLSUNSCREEN  SUNSCREEN LOTION SPF 34
avobenzone, octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59886-319
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	3 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	3 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: 59886-319-11	125 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	03/01/2010

Labeler - Fischer Pharmaceuticals Ltd (600158976)

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