The following Structured Product Label (SPL) was submitted to the FDA by Fischer Pharmaceuticals Ltd. for the product Ultrasolsunscreen (NDC 59886-316). 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, flammable:, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients Purpose
Avobenzone 2.0%, Octinoxate 7.5%, Octisalate 5.0%,
Octocrylene 9.0%, Oxybenzone 4.0% ................................................ Sunscreen
• 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
For external use only
Do not use near heat, flame, or while smoking. Avoid long term storage above 40C (104F)
• 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
rash or irritation develops and lasts.
If swallowed, get medical help or contact a Poison
Control Center immediately.
• 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
• 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.
Acrylates/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, Isobutylparaben, Menthyl Lactate,
Methylparaben, Panthenol, Phenoxyethanol, Potassium Cetyl Phosphate, Propane / Butane /
Isobutane, Propylparaben, Sorbitane Oleate, Tocopheryl Acetate, VP/Eicosene Copolymer,
Water.
Call 1-877-212-1985 Mon-Fri
Dr. Fischer
ULTRASOL
KIDS Sunscreen Mousse SPF30
Broad Spectrum
UVA and UVB Protection
Dermatologist Recommended
Fun Melon Fragrance
SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY
VERY WATER RESISTANT
Hypoallergenic
200 ML. 6.77 FL. OZ.
FISCHER PHARMACEUTICALS
Manufactured by:
Fischer Pharmaceuticals Ltd.
Bnei Brak, Israel, 51553
Made in Israel
www.dr-fischer.com
24m
NO CFCs
NO ANIMAL INGREDIENTS NO ANIMAL TESTING
Dr. Fischer - Tried and Tested
Pdp And Back (67059 Kids Mousse)
* Please review the disclaimer below.
