ULTRASOLSUNSCREEN NATURE BABY SUNSCREEN FACE CREAM SPF 45- 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

nature BABY

Sunscreen SPF 45

Face Cream

Broad Spectrum

UVA and UVB Protection

Pediatrician Recommended

With Oatmeal and Aloe Vera

SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY

VERY WATER RESISTANT

Ophthalmologically Tested

Non-Irritating

RECOMMENDED - SKIN CANCER FOUNDATION

50 ML. 1.69 FL. OZ.

(Back of the package):

Manufactured by:

Fischer Pharmaceuticals Ltd.

Bnei Brak, Israel, 51553

Made in Israel

www.dr-fischer.com

NO ANIMAL INGREDIENTS - NO ANIMAL TESTING

24m

FISCHER PHARMACEUTICALS

Drug Facts

Active Ingredients                                                                                 Purpose
Avobenzone 2.0%, Octinoxate 7.5%, Octisalate 5.0%,
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

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, Aloe
Barbadensis (Aloe Vera) Leaf Extract, Avena Sativa (Oat) Kernel Extract,
Butylparaben, Calendula officinalis Flower Oil, Chamomilla Recutita (Matricaria)
Extract, 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  NATURE BABY SUNSCREEN FACE CREAM SPF 45
avobenzone, octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59886-337
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
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)
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: 59886-337-77	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