Otc - Active Ingredient
Zinc Oxide 18%
Re Screen Broad Spectrum Spf 30 Sunscreen Stick
FDA Label NDC 87608-001
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 Re Screen Broad Spectrum Spf 30 Sunscreen (NDC 87608-001). 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
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
Directions Apply liberally 15 minutes
before sun exposure Reapply after 80
minutes of swimming or sweating
immediately after towel drying at least
every 2 hours Children under 6 months:
Ask a doctor 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: (cont.)
Inactive Ingredient
Olea Europaea (Olive) Oil, Beeswax, Simmondsia
Chinensis (Jojoba) Seed Oil,
Theobroma Cacao (Cocoa)
Seed Butter, Butyrospermum
Parkii (Shea) Butter,Tocopheryl Acetate
Storage And Handling
Other information
Protect this product from
excessive heat and direct sun.
* Please review the disclaimer below.
