ULTRASOL KIDS- avobenzone, octinoxate, octisalate, octocrylene, oxybenzone aerosol, foam

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%,
Octocrylene 9.0%, 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

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/C10-30 Alkyl Acrylate Crosspolymer,
Aminomethyl Propanol, Butylparaben, Camellia Sinensis Leaf Extract, Cetyl Dimethicone,
Chamomilla Recutita (Matricaria) Extract, Chlorphenesin, Dicaprylyl Ether, Disodium
EDTA, Ethylparaben, Fragrance, Glycerin, Isobutylparaben, Menthyl Lactate, Methylparaben,
Panthenol, Phenoxyethanol, Potassium Cetyl Phosphate, Propane/Butane/Isobutane,
Propylparaben, Sorbitane Oleate, Tocopheryl Acetate, VP/Eicosene Copolymer, Water.

Questions or Comments?

Call 1-877-212-1985 Mon-Fri

PRINCIPAL DISPLAY PANEL

Dr. Fischer

ULTRASOL

KIDS Sunscreen Mousse SPF30

Broad Spectrum UVA and UVB Protection

Dermatologist Recommended

Fun Melon Fragrance

SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY

VERY WATER RESISTANT

Hypoallergenic

200 ML. 6.77 FL. OZ.

FISCHER PHARMACEUTICALS

NO ANIMAL INGREDIENTS NO ANIMAL TESTING

24M

NO CFCs

Manufactured by:

Fischer Pharmaceuticals Ltd.

Bnei Brak, Israel, 51553

Made in Israel

www.dr-fischer.com

Dr. Fischer - Tried and Tested

INGREDIENTS AND APPEARANCE

ULTRASOL  KIDS
avobenzone, octinoxate, octisalate, octocrylene, oxybenzone aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59886-353
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
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	9 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)
Glycerin (UNII: PDC6A3C0OX)
Methylparaben (UNII: A2I8C7HI9T)
Panthenol (UNII: WV9CM0O67Z)
Phenoxyethanol (UNII: HIE492ZZ3T)
Propane (UNII: T75W9911L6)
Isobutane (UNII: BXR49TP611)
Butane (UNII: 6LV4FOR43R)
Propylparaben (UNII: Z8IX2SC1OH)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59886-353-66	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	06/10/2010

Labeler - Fischer Pharmaceuticals Ltd. (600158976)

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