ULTRASOLSUNSCREEN SUNSCREEN SPRAY LOTION SPF 15- avobenzone, octinoxate, oxybenzone 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 2.0%, Octinoxate 7.5%,
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/C 10-30 Alkyl Acrylate
Crosspolymer, Aminomethyl Propanol, Butylparaben, Cetyl
Dimethicone, Chamomilla Recutita (Matricaria) Extract,
Dicaprylyl Ether, Disodium EDTA, Ethylparaben, Fragrance,
Glycerin, Iodopropynyl Butylcarbamate, Menthyl Lactate,
Methylparaben, Panthenol, Phenoxyethanol, Potassium Cetyl
Phosphate, Propylparaben, Sorbitan Oleate, Tocopheryl Acetate,
VP/Eicosene Copolymer, Water

Questions or Comments?

Call 1-877-212-1985 Mon-Fri

PRINCIPAL DISPLAY PANEL

Dr. Fischer ULTRASOL

Sunscreen Spray Lotion

SPF 15

Broad Spectrum UVA and UVB Protection

Dermatologist Recommended

SCIENCE INSIDETM - SUPERIOR SUN TECHNOLOGY

VERY WATER RESISTANT

Hypoallergenic

200 ML. 6.77 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

INGREDIENTS AND APPEARANCE

ULTRASOLSUNSCREEN  SUNSCREEN SPRAY LOTION SPF 15
avobenzone, octinoxate, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59886-330
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
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Butylparaben (UNII: 3QPI1U3FV8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Ethylparaben (UNII: 14255EXE39)
Glycerin (UNII: PDC6A3C0OX)
Methylparaben (UNII: A2I8C7HI9T)
Panthenol (UNII: WV9CM0O67Z)
Phenoxyethanol (UNII: HIE492ZZ3T)
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: 59886-330-66	200 g in 1 BOTTLE, SPRAY

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