Ultrasolsunscreen
FDA Label NDC 59886-320

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 59886-320). 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.

Label Section Quick Index

Drug Facts

Active Ingredients                                                                                             PurposeAvobenzone 2.0%, Octinoxate 7.5%, Octisalate 3.0%, Oxybenzone 3.0% ....... 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 rinsethoroughly with water.

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 PoisonControl 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

Other Information

• may stain some fabrics• Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreensmay reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredients

Acrylates / C10-30 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

Package Label.Principal Display Panel

Pdp And Back (67067 Lotion)

Pdp And Back (67067 Lotion)

Dr. Fischer Ultrasol

Sunscreen Lotion

SPF 34

Broad Spectrum

UVA and UVB Protection

Dermatologist Recommended

SCIENCE INSIDETM - SUPERIOR SUN TECHNOLOGY

VERY WATER RESISTANT

Hypoallergenic

Sensitive Approved

RECOMMENDED - SKIN CANCER FOUNDATION

250 ML. 8.45 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

* Please review the disclaimer below.