Active Ingredients
Zinc Oxide 18%
Prequel Sun Barrier Mineral Sunscreen Broad Spectrum Spf 50 Cream
FDA Label NDC 82800-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Center Brands, Llc for the product Prequel Sun Barrier Mineral Sunscreen Broad Spectrum Spf 50 (NDC 82800-010). 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 active ingredients, uses, warnings, directions, inactive ingredients, other information, questions?, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Warnings
For external use only
Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a docor if rash occurs
Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.
Directions
• apply generously 15 minutes before sun exposure
• reapply: •at least every 2 hours.
• use a water resistant sunscreen if swimming or sweating
• 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
• children under 6 months of age: Ask a doctor
Inactive Ingredients
Water (Aqua), Caprylic/Capric Triglyceride, Diisooctyl Succinate, Butyloctyl Salicylate, Propanediol, Glycerin, Cetearyl Olivate, Polyhydroxystearic Acid, Sorbitan Olivate, Polyhydroxystearic Acid, Sorbitan Olivate, Bisabolol, Pongamia Pinnata Seed Extract, Zingiber Officinale Root Extract, Tetrahydrodiferuloylmethane, Tetrahydrodemethoxydiferuloylmethane, Tetrahydrodemethoxydiferuloylmethane, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita Flower Extract, Centella Asiatica Extract, Phenoxyethanol, Polyglyceryl-4 Laurate/Succinate, Lauroyl Lysine, Triethoxycaprylylsilane, Arachidyl Alcohol, Silica, Xanthan Gum, Potassium Cetyl Phosphate, Behenyl Alcohol, Caprylyl Glycol, VP/Eicosene Copolymer, Arachidyl Glucoside, Tetrasodium Glutamate Diacetate, Ethylhexylglycerin, Tocopheryl Acetate, Cetyl Alcohol, Tin Oxide, Isononyl Isononanoate, Ethylene/Propylene/Styrene Copolymer, Soribitan Oleate, Titanium Dioxide (CI 77891), Mica (CI 77019), Iron Oxides (CI 77499, CI 77491)
Other Information
• protect the product in this container from excessive
heat and direct sun
Questions?
Visit prequelskin.com
Principal Display Panel
82800-010-01 (82800 010 01)
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