Active Ingredients
Octisalate 3.2%
Octocrylene 6%
Sunscreen Liquid
FDA Label NDC 84203-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Baxter Of California, Llc for the product Sunscreen (NDC 84203-001). 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 active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask doctor if, 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
Purpose
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
Warnings
For external use only
Do Not Use
on damamged skin or broken skin
When Using This Product
Keep out of eyes.
Rinse with water to remove
Stop Use And Ask Doctor If
rash occurs
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
For sunscreen use:
- apply liberally 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 10am-2pm
- wear long sleeved shirts, pants, hats, and sunglasses
- children under 6 months of age: Ask a doctor
Other Information
protect the product in this container from excessive heat and direct sun
Inactive Ingredients
water, undecane, dimethicone, glycerin, tridecane, polyglyceryl-4 isostearate, pentylene
glycol, cetyl PEG/PPG-10/1, hexyl laurate, magnesium sulfate, disteardimonium hectorite,
trihydroxystearin, cellulose gum, aluminum hydroxide, disodium stearoyl glutamate,
acetylated glycol stearate, acrylates copolymer, ethylhexylglyceerin; may contain:
titanium dioxide, iron oxides
Questions Or Comments?
1-877-900-6700
Monday - Friday (9 a.m. - 5 p.m. EST)
* Please review the disclaimer below.
