Ultrasolsunscreen
FDA Label NDC 59886-340

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fischer Pharmaceuticals Ltd for the product Ultrasolsunscreen (NDC 59886-340). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredients                                                                                 Purpose
Avobenzone 2.5%, Homosalate 5.0%, Octinoxate 7.5%,
Octisalate 5.0%, Octocrylene 9.0%, 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

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

Acrylate/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol,
Butylparaben, Camellia Sinensis Leaf Extract, 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

Package Label.Principal Display Panel

Pdp And Back (67073 Spray)

Pdp And Back (67073 Spray)

Dr. Fischer

Ultrasol

Sport Sunscreen Lotion

CONTINUOUS SPRAY

SPF45

Broad Spectrum UVA and UVB Protection

Dermatologist Recommended

SCIENCE INSIDETM - SUPERIOR SUN TECHNOLOGY

VERY WATER RESISTANT

VERY SWEAT RESISTANT

NON GREASY

RECOMMENDED - SKIN CANCER FOUNDATION

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

NO CFCs - CONTAINS NO CFCs WHICH DEPLETE THE OZONE LAYER

24m

Dr. Fischer - Tried and Tested


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