Dr. Fischer Ultrasol Sunscreen Lotion Spf34

Dr. Fischer Ultrasol Sunscreen Lotion Spf34
SPL v3
SPL
SPL Set ID 9321ad29-30c7-4134-8f7c-646990ee8cdf
Route
TOPICAL
Published
Effective Date 2010-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2 g) Octinoxate (7.5 g) Octisalate (3 g) Oxybenzone
Inactive Ingredients
Butylparaben Chlorphenesin Edetate Disodium Ethylparaben Glyceryl Monostearate Isopropyl Myristate Methylparaben Phenoxyethanol Propylene Glycol Propylparaben Sodium Hydroxide Stearic Acid Stearyl Alcohol Alpha-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-03-01

Description

Dr. Fischer ULTRASOL Sunscreen Lotion SPF34 Broad Spectrum UVA and UVB Protection Dermatologist Recommended SCIENCE INSIDE TM SUPERIOR SUN TECHNOLOGY VERY WATER RESISTANT Hypoallergenic Sensitive Approved RECOMMENDED - SKIN CANCER FOUNDATION 125 ML. 4.22 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


Medication Information

Description

Dr. Fischer ULTRASOL Sunscreen Lotion SPF34 Broad Spectrum UVA and UVB Protection Dermatologist Recommended SCIENCE INSIDE TM SUPERIOR SUN TECHNOLOGY VERY WATER RESISTANT Hypoallergenic Sensitive Approved RECOMMENDED - SKIN CANCER FOUNDATION 125 ML. 4.22 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

Uses

• helps prevent sunburn • higher SPF gives more sunburn protection

• helps protect the skin against the h armful 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 Lotion

SPF34

Broad Spectrum UVA and UVB Protection

Dermatologist Recommended

SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY

VERY WATER RESISTANT Hypoallergenic

Sensitive Approved

RECOMMENDED - SKIN CANCER FOUNDATION

125 ML. 4.22 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

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

Drug Facts
Active Ingredients                                                                                 Purpose

Avobenzone 2.0%, Octinoxate 7.5%, Octisalate 3.0%,

Oxybenzone 3.0% ........................................................................... Sunscreen
Other Information

• may stain some fabrics • Sun alert: Limiting sun

exposure, wearing protective clothing, and using sun screens may reduce th e

risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredients

Acrylates / C 10-30 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

When Using This Product

avoid contact with the eyes. If contact occurs

rinse thoroughly with water.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a

Poison Control Center immediately.

Stop U S E and Ask A Doctor If

rash or irritation develops and lasts.


Structured Label Content

Uses

• helps prevent sunburn • higher SPF gives more sunburn protection

• helps protect the skin against the h armful 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 Lotion

SPF34

Broad Spectrum UVA and UVB Protection

Dermatologist Recommended

SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY

VERY WATER RESISTANT Hypoallergenic

Sensitive Approved

RECOMMENDED - SKIN CANCER FOUNDATION

125 ML. 4.22 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

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

Drug Facts
Active Ingredients                                                                                 Purpose

Avobenzone 2.0%, Octinoxate 7.5%, Octisalate 3.0%,

Oxybenzone 3.0% ........................................................................... Sunscreen
Other Information

• may stain some fabrics • Sun alert: Limiting sun

exposure, wearing protective clothing, and using sun screens may reduce th e

risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredients

Acrylates / C 10-30 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? (Questions or Comments?)

Call 1-877-212-1985 Mon-Fri

When Using This Product (When using this product)

avoid contact with the eyes. If contact occurs

rinse thoroughly with water.

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

If swallowed, get medical help or contact a

Poison Control Center immediately.

Stop U S E and Ask A Doctor If (Stop u s e and ask a doctor if)

rash or irritation develops and lasts.


Advanced Ingredient Data


Raw Label Data

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