Otc - Active Ingredient
Homosalate,Octocrylene,Octisalate,Avobenzone
Poolside Golden Hour Spf15 Sunscreen Lip Oil
FDA Label NDC 85161-161
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Longway Technology(guangzhou)co.,ltd. for the product Poolside Golden Hour Spf15 Sunscreen Lip Oil (NDC 85161-161). 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 - keep out of reach of children, otc - questions, other safety information, warnings, dosage & administration, indications & usage, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children
If product is swallowed get meditcal help or contact avpoison control center rnigh away.
Otc - Questions
1-212-244-5170| [email protected]
Other Safety Information
Protect the product in this container from excessive heat and direct sun.
Warnings
For external use only.
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 help prevent sunburn, not skin cancer or early skin aging.
Do not use on damaged or broken skin.
When using this product.
keep out of eves. rinse with water to remove.
Stop use and ask doctor if rash occurs.
Keep out of reach of children.
lf product is swallowed get medical help or contact a poison control center right away
Dosage & Administration
Apply generously and evenly 15 minuies before sun exposure.
Reaply at least every 2 hour.
Use a water resistant sunscreen if swimming or sweating.
Children under 6 month: ask a doctor.
Indications & Usage
Helps prevent sunburn.
Inactive Ingredient
POLYISOBUTENE,HYDROGENATED POLYISOBUTENE,OCTYLDODECANOL,VP/HEXADECENE COPOLYMER,MENTHOL,FRAGRANCE,GLYCERYL CAPRYLATE,MENTHOXYPROPANEDIOL,BHT,ALUMINUM HYDROXIDE,WATER,TOCOPHEROL,SODIUM SULFATE,SODIUM CHLORIDE,YELLOW 5 LAKE(CI 45410)
Otc - Purpose
Sunscreen
* Please review the disclaimer below.
