Drug Facts
Active Ingredients Purpose
Titanium Dioxide 15.0%, Zinc Oxide 8.0%.......................................... Sunscreen
Ultrasol
FDA Label NDC 59886-349
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 Ultrasol (NDC 59886-349). 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
Aloe Barbadensis (Aloe Vera) Leaf Extract, Alumina,
Aluminum Stearate, Avena Satina (Oat) Kernel Oil, C20-40 Acid, Calendula
Officinalis Flower Oil, Camellia Sinensis Leaf Extract, Caprylic / Capric Triglyceride,
Cetyl Dimethicone, Cetyl PEG/PPG 10/1 Dimethicone, Chamomile Oil, Coco
Nucifera (Coconut) Oil, Cyclomethicone, Diazolidinyl Urea, Dimethicone, Ethylhexyl
Palmitate, Fragrance, Hydrogenated Castor Oil, Isododecane, Methylparaben,
Mineral Oil, Panthenol, Polyethylene, Polyhydroxystearic Acid, Propylene Glycol,
Propylparaben, Sodium Chloride, Tocopheryl Acetate, Water.
Questions Or Comments?
Call 1-877-212-1985 Mon-Fri
Package Label.Principal Display Panel
Dr. Fischer ULTRASOL
nature BABY Sunscreen Lotion SPF50
Broad Spectrum UVA and UVB Protection
Pediatrician Recommended
With Oatmeal and Aloe Vera
SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY
VERY WATER RESISTANT
Hypoallergenic
Non-Irritating
Ophthalmologically Tested
RECOMMENDED SKIN CANCER FOUNDATION
200 ML. 6.77 FL. OZ.
FISCHER PHARMACEUTICALS
Manufactured by:
Fischer Pharmaceuticals Ltd.
Bnei Brak, Israel, 51553
Made in Israel
www.dr-fischer.com
Dr. Fischer - Tried and Tested
Pdp And Back (Baby Spf50 200ml)
* Please review the disclaimer below.
