Drug Facts
Active Ingredients Purpose
Avobenzone 2.0%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 4.0% ....... Sunscreen
Ultrasolsunscreen
FDA Label NDC 59886-309
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 59886-309). 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
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.
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
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 / 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 (67058 Lotion)
Dr. Fischer ULTRASOL
KIDS Sunscreen Lotion SPF45
Broad Spectrum UVA and UVB Protection
Pediatrician Recommended
Fun Melon Fragrance
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.
