Otc - Purpose
Sunscreen
The following Structured Product Label (SPL) was submitted to the FDA by Bullfrog Brands, Llc for the product Bull Frog Spf 50 (NDC 77714-002). 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 otc - purpose, indications & usage, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Sunscreen
Uses • helps prevent sunburn • if used as directed with other sun protection measures ( See Directions)
decreases the risk of skin cancer and early skin aging caused by the sun.
Directions • Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months of age: ask a doctor. • Reapply: • after 80 minutes of swimming or sweating
• immediately after towel drying • at least every 2 hours. • Sun
Protection Measures. Spending time in the sun increases your
risk of skin cancer and early skin aging. To decrease this risk,
regularly use a sunscreen with a Broad Spectrum SPF value of 15
or higher and other sun protection measures including: • limit time
in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved
shirts, pants, hats, and sunglasses. • Hold container 4 to 6 inches
from the skin to apply. • Do not spray directly into face. Spray on
hands then apply to face. • Do not apply in windy conditions.
• Use in a well-ventilated area. • For sunscreen use: • apply to all
skin exposed to the sun. • Reapply as needed or after towel
drying, swimming, or sweating.
Inactive Ingredients:
Acacia Famesiana extract, acrylate/octyl acrylamide copolymer, aloe barbadensis leaf extract, camellia sinensis leaf extract, chamomile flower extract, cyclohexasiloxane, cyclopentasiloxane, ethylhexyl palmitate, fragrance, glycerin, hydroxypropyl cellulose, isopropyl myrsitate, lavender extract, phenethyl benzoate, PPG-12 copolymer, propylene glycol, rosemary leaf extract, SD Alcohol 40, Tocopheryl (Vitamin E) Acetate.
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