Otc - Active Ingredient
Zinc Oxide 15.4%
Screen Screen Broad Spectrum Spf 30 Sunscreen Lotion
FDA Label NDC 87608-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zouck Llc for the product Screen Screen Broad Spectrum Spf 30 Sunscreen (NDC 87608-002). 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 - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
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
Warnings
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison
Control Center right away
Dosage & Administration
Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water-resistant sunscreen if swimming
or sweating Chlldren under 6 months: Ask a doctor
Inactive Ingredient
Inactive ingredients
Water, Octyldodecyl Myristate, Glycerin, Polyglyceryl-3 Diisostearate, Triheptanoin,
Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyhydroxystearate, C13-16 Isoalkane,
Polyglyceryl-6 Polyricinoleate, Cetearyl Olivate, Tocopherol, Ethyl Ferulate,
Triethoxycaprylylsilane, Polyglycerin-6, Sorbitan Olivate, Stearalkonium Hectorite,
Propylene Carbonate, Silica, Cera Alba (Beeswax), Portulaca Oleracea Extract,
Butylene Glycol, Withanla Somnifera Root Extract, Theobroma Cacao (Cocoa) Seed
Butter, Caesalpinia Spinosa Fruit Extract, Propanediol, Tremella Fuciformis
Sporocarp Extract, Betaine, Pongamia Glabra Seed Oil, Glycine Soja (Soybean) Oil,
Oryza Sativa (Rice] Extract, Oryza Sativa (Rice) Germ Extract, Camellia Sinensis Leaf
Extract, Sodium Chloride, Tetrasodium Glutamate Diacetate, Fragrance (Natural)
Storage And Handling
Protect the product in this container from ​excessive heat and direct sun
Store at room temperature
Package Label.Principal Display Panel
Labeling (Lotion)
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