Indications & Usage
Helps prevent sunburn.
If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.
Sunscreen Spf50 Lotion
FDA Label NDC 85769-478
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Xinjie Cosmetics Co.,ltd. for the product Sunscreen Spf50 (NDC 85769-478). 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 indications & usage, otc - purpose, otc - when using, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, 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
Otc - Purpose
Sunscreen
Helps prevent sunburn
Otc - When Using
• 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 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.
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.
• Children under 6 months of age: 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:
• Limit time in the sun, especially from 10 a.m. – 2 p.m.
• Wear long-sleeve shirts, pants, hats, and sunglasses.
Inactive Ingredient
Water
Package Label.Principal Display Panel
Sunscreen SPF 50
Broad Spectrum
Water Resistant (80 minutes)
50 mL (1.69 fl oz)
Sunscreen (Sunscreen)
* Please review the disclaimer below.
