ULTRASOL NATURE BABY SUNSCREEN- titanium dioxide, zinc oxide cream

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
Titanium Dioxide 15.0%, Zinc Oxide 8.0%.......................................... 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

Aloe Barbadensis (Aloe Vera) Leaf Extract, Alumina,
Aluminum Stearate, Avena Satina (Oat) Kernel Oil, C20-40 Acid, Calendula
Officinalis Flower Oil, Camellia Sinensis Leaf Extract, Caprylic / Capric Triglyceride,
Cetyl Dimethicone, Cetyl PEG/PPG 10/1 Dimethicone, Chamomile Oil, Coco
Nucifera (Coconut) Oil, Cyclomethicone, Diazolidinyl Urea, Dimethicone, Ethylhexyl
Palmitate, Fragrance, Hydrogenated Castor Oil, Isododecane, Methylparaben,
Mineral Oil, Panthenol, Polyethylene, Polyhydroxystearic Acid, Propylene Glycol,
Propylparaben, Sodium Chloride, Tocopheryl Acetate, Water.

Questions or Comments?

Call 1-877-212-1985 Mon-Fri

PRINCIPAL DISPLAY PANEL

Dr. Fischer ULTRASOL

nature BABY Sunscreen Face Cream SPF50

Broad Spectrum UVA and UVB Protection

Pediatrician Recommended

SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY

VERY WATER RESISTANT

Non-Irritating

Ophthalmologically Tested

RECOMMENDED SKIN CANCER FOUNDATION

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

Extra gentle for baby's delicate skin

Gentle Baby Sun Care and Protection

Hypoallergenic

Sensitive-Tested

Light Texture

Rapidly Absorbed

Natural Herbal Complex to Care for Baby's Skin: Oatmeal, Aloe Vera,

Chamomile and Calendula

Vitamin E and Green Tea antioxidant protection against free radicals

50 ML. 1.69 FL. OZ.

100% NATURAL SUNSCREENS

Manufactured by:

Fischer Pharmaceuticals Ltd.

Bnei Brak, Israel, 51553

Made in Israel

www.dr-fischer.com

Fischer Pharmaceuticals

Dr. Fischer - Tried and Tested

24m

NO ANIMAL TESTING NO ANIMAL INGREDIENTS

INGREDIENTS AND APPEARANCE

ULTRASOL  NATURE BABY SUNSCREEN
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59886-304
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	15 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
Aluminum Stearate (UNII: U6XF9NP8HM)
Coconut Oil (UNII: Q9L0O73W7L)
Methylparaben (UNII: A2I8C7HI9T)
Panthenol (UNII: WV9CM0O67Z)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Chloride (UNII: 451W47IQ8X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59886-304-77	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	06/10/2010

Labeler - Fischer Pharmaceuticals Ltd (600158976)

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