ULTRASOLSUNSCREEN KIDS CLEAR CONTINUOUS SPRAY- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone aerosol, 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 3.0%, Homosalate 10.0%, Octinoxate 7.5%,
Octisalate 5.0%, Octocrylene 6.0%, Oxybenzone 5.0%...................... 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 / Octylacrylamide Copolymer,
Butylparaben, Ethylparaben, Green Tea (Camellia Sinensis) Leaf Extract,
Methylparaben, Phenoxyethanol,
Propylparaben, SD Alcohol 40, Tocopheryl Acetate

Questions or Comments?

Call 1-877-212-1985 Mon-Fri

PRINCIPAL DISPLAY PANEL

Dr. Fischer

ULTRASOL

KIDS Sunscreen Clear Spray SPF43

Clear CONTINUOUS SPRAY
Broad Spectrum UVA and UVB Protection
Pediatrician Recommended
Fun Melon Fragrance
SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY
VERY WATRE RESISTANT
Hypoallergenic
Sensitive Approved
RECOMMENDED - SKIN CANCER FOUNDATION
200ML. 6.77 FL. OZ.
FISCHER PHARMACEUTICALS
NO CFCs
24M
NO ANIMAL INGREDIENTS - NO ANIMAL TESTING
Manufactured by:
Fischer Pharmaceuticals Ltd.
Bnei Brak, Israel, 51553
Made in Israel
www.dr-fischer.com

INGREDIENTS AND APPEARANCE

ULTRASOLSUNSCREEN  KIDS CLEAR CONTINUOUS SPRAY
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59886-347
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 g  in 100 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	10 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	6 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Butylparaben (UNII: 3QPI1U3FV8)
Ethylparaben (UNII: 14255EXE39)
Methylparaben (UNII: A2I8C7HI9T)
Phenoxyethanol (UNII: HIE492ZZ3T)
Propylparaben (UNII: Z8IX2SC1OH)
Alcohol (UNII: 3K9958V90M)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59886-347-66	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	04/10/2010

Labeler - Fischer Pharmaceuticals Ltd (600158976)

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