The following Structured Product Label (SPL) was submitted to the FDA by Fischer Pharmaceuticals Ltd for the product Ultrasolsunscreen (NDC 59886-347). 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 3.0%, Homosalate 10.0%, Octinoxate 7.5%,
Octisalate 5.0%, Octocrylene 6.0%, Oxybenzone 5.0%...................... 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 40˚C (104˚F)
• 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 / Octylacrylamide Copolymer,
Butylparaben, Ethylparaben, Green Tea (Camellia Sinensis) Leaf Extract,
Methylparaben, Phenoxyethanol,
Propylparaben, SD Alcohol 40, Tocopheryl Acetate
Call 1-877-212-1985 Mon-Fri
Dr. Fischer
ULTRASOL
KIDS Sunscreen Clear Spray SPF43
Pdp And Back (67071 Kids Clear Continuous)
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