ULTRASOLSUNSCREEN KIDS SUNSCREEN LOTION SPF 34- avobenzone, octinoxate, octisalate, oxybenzone lotion

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

KIDS Sunscreen Lotion

SPF34

Broad Spectrum

UVA and UVB Protection

Pediatrician Recommended

SCIENCE INSIDETM - SUPERIOR SUN TECHNOLOGY

250 ML. 8.45 FL.OZ.

FISCHER PHARMACEUTICALS

(Back of Package):

Manufactured by:

Fischer Pharmaceuticals Ltd.

Bnei Brak, Israel, 51553

Made in Israel

www.dr-fischer.com

NO ANIMAL INGREDIENTS - NO ANIMAL TESTING

24m

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  KIDS SUNSCREEN LOTION SPF 34
avobenzone, octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59886-308
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)
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)
Water (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59886-308-55	250 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2010

Labeler - Fischer Pharmaceuticals Ltd (600158976)

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