Dr. Fischer Ultrasol Clear Continuous Spray Spf43

Dr. Fischer Ultrasol Clear Continuous Spray Spf43
SPL v2
SPL
SPL Set ID 09121ddb-3504-4da8-9f1b-ac981b29dee0
Route
TOPICAL
Published
Effective Date 2010-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octinoxate (7.5 g) Octisalate (5 g) Octocrylene (6 g) Oxybenzone
Inactive Ingredients
Butylparaben Ethylparaben Methylparaben Phenoxyethanol Propylparaben Alcohol Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-04-10

Description

Active Ingredients                                                                                 Purpose Avobenzone 3.0%, Homosalate 10.0%, Octinoxate 7.5%, Octisalate 5.0%, Octocrylene 6.0%, Oxybenzone 5.0%...................... Sunscreen


Medication Information

Description

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

Section 51945-4

Dr. Fischer

ULTRASOL

Sunscreen Clear Spray SPF43

Clear CONTINUOUS SPRAY

Broad Spectrum UVA and UVB Protection

Dermatologist Recommended

SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY

VERY WATER RESISTANT

Hypoallergenic

Non Irritating

RECOMMENDED - SKIN CANCER FOUNDATION

200 ML. 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

Dr. Fischer - Tried and Tested

Warnings

For external use only

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

Drug Facts

Active Ingredients                                                                                 Purpose

Avobenzone 3.0%, Homosalate 10.0%, Octinoxate 7.5%,

Octisalate 5.0%, Octocrylene 6.0%, Oxybenzone 5.0%...................... Sunscreen

Flammable:

Do not use near heat, flame, or while smoking. Avoid long term

storage above 40˚C (104˚F)

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

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.


Structured Label Content

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

Section 51945-4 (51945-4)

Dr. Fischer

ULTRASOL

Sunscreen Clear Spray SPF43

Clear CONTINUOUS SPRAY

Broad Spectrum UVA and UVB Protection

Dermatologist Recommended

SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY

VERY WATER RESISTANT

Hypoallergenic

Non Irritating

RECOMMENDED - SKIN CANCER FOUNDATION

200 ML. 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

Dr. Fischer - Tried and Tested

Warnings

For external use only

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

Drug Facts

Active Ingredients                                                                                 Purpose

Avobenzone 3.0%, Homosalate 10.0%, Octinoxate 7.5%,

Octisalate 5.0%, Octocrylene 6.0%, Oxybenzone 5.0%...................... Sunscreen

Flammable:

Do not use near heat, flame, or while smoking. Avoid long term

storage above 40˚C (104˚F)

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

When Using This Product (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 (Stop use and ask a doctor if)

rash or irritation develops and lasts.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a

Poison Control Center immediately.


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