Otc - Active Ingredient
Ethylhexyl Methoxycinnamate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane
Waterful Sun
FDA Label NDC 71496-0003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ari&j Inc for the product Waterful Sun (NDC 71496-0003). 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, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Water, Butylene Glycol, etc
Otc - Purpose
- Suncreen
- protects skin from UV rays
- 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
Otc - Keep Out Of Reach Of Children
keep out or reach of the children
Indications & Usage
apply generously 15 minutes before sun sxposure
reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every two hours
- limit time in the sun, expecially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
Sun Protection Measures. Spending thime 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:
children under 6 months of age: Ask a doctor
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 doctor if rash occurs.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- do not place this product in this container in the excessive heat and direct sun.
Dosage & Administration
for external use only
Package Label.Principal Display Panel
Label (Label)
* Please review the disclaimer below.
