Otc - Active Ingredient
Homosalate 15%, Octocrylene 10%, Octisalate 5% , Avobenzone 3%
Poolside Butter Screen Spf 30 Sunscreen Butter Oil
FDA Label NDC 85161-165
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 Butter Screen Spf 30 Sunscreen Butter (NDC 85161-165). 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, otc - keep out of reach of children, otc - questions, dosage & administration, warnings, other safety information, 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.
Otc - 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]
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.
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 m 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.
Other Safety Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredient
WATER，PROPYLENE GLYCOL，BEHENYL ALCOHOL，GLYCERYL STEARATE，CETEARYL ALCOHOL，PEG-100 STEARATE，1,2-HEXANEDIOL，PHENOXYETHANOL，FRAGRANCE，POTASSIUM CETYL PHOSPHATE，SILICA，XANTHAN GUM，TREHALOSE，SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL，TOCOPHERYL ACETATE，COCOS NUCIFERA (COCONUT) OIL，BUTYROSPERMUM PARKII (SHEA) BUTTER，ETHYLHEXYLGLYCERIN，DISODIUM EDTA，ALLANTOIN，METHICONE
Package Label.Principal Display Panel
Poolside Butter Screen Spf 30 Sunscreen Butter (27)
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