ULTRASOLSUNSCREEN CLEAR CONTINUOUS SPRAY SPF43- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone aerosol, spray

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]

Drug Facts

Active Ingredients                                                                                 Purpose
Avobenzone 3.0%, Homosalate 10.0%, Octinoxate 7.5%,
Octisalate 5.0%, Octocrylene 6.0%, Oxybenzone 5.0%...................... 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

Flammable:

Do not use near heat, flame, or while smoking. Avoid long term
storage above 40˚C (104˚F)

When using this product

avoid contact with the eyes. If contact occurs
rinse thoroughly with water
do not puncture or incinerate. Contents under pressure. Do not store at
temperatures above 120˚F

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
do not spray directly on face. Spray into hands and apply to face
use in well-ventilated areas

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 / Octylacrylamide Copolymer,
Butylparaben, Ethylparaben, Green Tea (Camellia Sinensis) Leaf Extract,
Methylparaben, Phenoxyethanol,
Propylparaben, SD Alcohol 40, Tocopheryl Acetate

PRINCIPAL DISPLAY PANEL

Dr. Fischer

ULTRASOL

Sunscreen Clear Spray SPF43

Clear CONTINUOUS SPRAY

Broad Spectrum UVA and UVB Protection

Dermatologist Recommended

SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY

VERY WATER RESISTANT

Hypoallergenic

Non Irritating

RECOMMENDED - SKIN CANCER FOUNDATION

200 ML. 6.77 FL. OZ.

FISCHER PHARMACEUTICALS

NO CFCs

24M

NO ANIMAL INGREDIENTS - NO ANIMAL TESTING

Manufactured by:

Fischer Pharmaceuticals Ltd.

Bnei Brak, Israel, 51553

Made in Israel

www.dr-fischer.com

Dr. Fischer - Tried and Tested

INGREDIENTS AND APPEARANCE

ULTRASOLSUNSCREEN  CLEAR CONTINUOUS SPRAY SPF43
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59886-346
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 g  in 100 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	10 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
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	6 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Butylparaben (UNII: 3QPI1U3FV8)
Ethylparaben (UNII: 14255EXE39)
Methylparaben (UNII: A2I8C7HI9T)
Phenoxyethanol (UNII: HIE492ZZ3T)
Propylparaben (UNII: Z8IX2SC1OH)
Alcohol (UNII: 3K9958V90M)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59886-346-66	200 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/10/2010

Labeler - Fischer Pharmaceuticals Ltd (600158976)

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