Otc - Active Ingredient
Homosalate 5%, Octocrylene 4.5%, Octisalate 4%, Avobenzone 3%
Poolside Frostbite Sunscreen Papaya Spf 15 Scented Lip Gloss Liquid
FDA Label NDC 85161-159
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 Frostbite Sunscreen Papaya Spf 15 Scented Lip Gloss (NDC 85161-159). 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 - purpose, indications & usage, warnings, otc - questions, inactive ingredient, other safety information, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
Helps prevent sunburn
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 eyes. rinse with water to remove.
Stop use and ask doctor if rash occurs.
Keep out of reach of children. If product is swallowed get medical help or contact a poison control center right away
Otc - Questions
1-212-244-5170 [email protected]
Inactive Ingredient
POLYISOBUTENE, HYDROGENATED POLYISOBUTENE, VP/HEXADECENE COPOLYMER, OCTYLDODECANOL, MENTHOL, FRAGRANCE, GLYCERYL CAPRYLATE, MENTHOXYPROPANEDIOL, BHT, ALUMINUM HYDROXIDE, WATER, TOCOPHEROL, SODIUM SULFATE, SODIUM CHLORIDE, FD&C YELLOW NO. 5 ALUMINUM LAKE(CI 19140).
Other Safety Information
Protect the product in this container from excessive heat and direct sun.
Dosage & Administration
Apply generously and evenly 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
Children under 6 month: ask a doctor.
Otc - Keep Out Of Reach Of Children
If product is swallowed get medical help or contact a poison control center right away
Package Label.Principal Display Panel
Poolside Frostbite Sunscreen Papaya Spf 15 Scented Lip Gloss (21)
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