Drug Facts
Active Ingredients PurposeAvobenzone 2.0%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 4.0% ....... Sunscreen
Ultrasol
FDA Label NDC 59886-355
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 59886-355). 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
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
Section TextDr. Fischer ULTRASOLSunscreen Lotion SPF 45Broad Spectrum UVA and UVB ProtectionDermatologist RecommendedScience InsideTM Superior Sun TechnologyVery Water ResistantHypoallergenic Sensitive ApprovedRecommended - Skin Cancer Foundation125 ML. 4.22 FL. OZ.FISCHER PHARMACEUTICALS(Back of Package):Manufactured by:Fischer Pharmaceuticals Ltd.Bnei Brak, Israel, 51553Made in Israelwww.dr-fischer.comNO ANIMAL INGREDIENTS - NO ANIMAL TESTING24mDr. Fischer Tried and Tested
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