Active Ingredients:
Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 6.0%, Titanium Dioxide 2.6%
Spf 50 Stay Put Sunscreen
FDA Label NDC 70392-015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sawyer Products for the product Spf 50 Stay Put Sunscreen (NDC 70392-015). 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, keep out of reach of children., when using this product, stop use and ask a doctor, 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.
Warnings:
Skin Cancer/Skin Aging Alert
Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
·
For external use only.
Do Not Use
on broken or damaged skin.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
When Using This Product
keep out of eyes. Rinse with warm water to remove.
Stop Use And Ask A Doctor
if rash occurs.
Directions:
· Apply liberally to cool, dry skin 15 minutes before sun exposure.
· Use a water resistant sunscreen if swimming or sweating.
· Reapply at least every 2 hours.
· For children under 6 months of age: ask a doctor before using.
Other Information:
· Protect this product container from excessive heat and direct sun.
Inactive Ingredients:
Aloe Barbadensis Leaf Juice, Dicaprylyl Maleate, Neopentyl Glycol Diethylhexanoate (and) Neopentyl Glycol Diisostearate, Octyldodecyl Neopentanoate, PEG-30 Dipolyhydroxystearate, Phenoxyethanol (and) Methyl paraben (and) Ethylparaben (and) Butylparaben (and)
Propyl paraben (and) Isobutylparaben, Poly ethylene, Poly quaternium 37 (and) Propylene Glycol Dicaprylate/Dicaprate (and) PPG-1 Trideceth-6, Water
Package Labeling:
Outer (Outer)
Inner (Inner)
* Please review the disclaimer below.
