Dr. Fischer Ultrasol Kids Clear Continuous Spray Spf43

Dr. Fischer Ultrasol Kids Clear Continuous Spray Spf43
SPL v3
SPL
SPL Set ID 3c8ec6df-04b8-45a1-9f23-f36622305e06
Route
TOPICAL
Published
Effective Date 2010-03-22
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

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















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

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

• 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

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















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

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

• 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.


Advanced Ingredient Data


Raw Label Data

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