ULTRASOLSUNSCREEN SUNSCREEN FACE CREAM SPF 34- avobenzone, octinoxate, octisalate, oxybenzone cream

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 Face Cream SPF34

Broad Spectrum UVA and UVB Protection

Dermatologist Recommended

SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY

VERY WATER RESISTANT

Hypoallergenic

Sensitive approved

50 ML. 1.69 FL. OZ.

RECOMMENDED - SKIN CANCER FOUNDATION

Manufactured by:

Fischer Pharmaceuticals Ltd.

Bnei Brak, Israel, 51553

Made in Israel

www.dr-fischer.com

24m

NO ANIMAL TESTING - NO ANIMAL INGREDIENTS

Extra moisture for delicate face and neck areas

Moisturizing Care and Sun Protection

Light Texture

Rapidly Absorbed

Soothes and calms the skin with Chamomile

Vitamin E and Green Tea antioxidant protection against free radicals

Tested according to the most stringent international sunscreen standards

This product is recommended by the American Skin Cancer Foundation as an effective UV sunscreen

FISCHER PHARMACEUTICALS

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 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

INGREDIENTS AND APPEARANCE

ULTRASOLSUNSCREEN  SUNSCREEN FACE CREAM SPF 34
avobenzone, octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59886-326
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: 59886-326-77	1 in 1 BOX
1		50 g in 1 TUBE

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