Otc - Active Ingredient
Homosalate 10%
Octocrylene 8%
Octilsalate 5%
Avobenzone 3%
Orlaskin Hydrating Sunscreen Spray
FDA Label NDC 83447-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Fantesy Biotechnology Co.,ltd for the product Orlaskin Hydrating Sunscreen (NDC 83447-003). 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, uses, warnings, otc - do not use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
sunscreen
Uses
Helps prevent sunburn.
If used as directed with other sun protection measures ( see directions ), decreases the risk of skin cancer and early skin ageing caused by the sun.
Warnings
For external use only.
Avoid contact with eyes , wear protective clothing , hats and eyewear when exposed to the sun . Avoid prolonged exposure in the sun.
Keep out of reach of children.
Do not use on damaged or brokenskin.
Store in a cool , dry place and avoiddirect sunlight.
If using with other sun protection products , consult with a doctor before use.
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Directions
Shake the spray bottle well before use.
Hold the spray bottle at an appropriate distance from the face and neck . Spray evenly onto the entire face and neck area.
Avoid direct contact with eves . In case of eye contact , rinse immediately with water.
For continued sun protection , reapply every 2 hours
Other Information
Protect the product in this container from excessive heat and direct sun
Inactive Ingredients
Auqa , Methacrylate Copolymer , Alcohol Denat , Bisabolol , Hvaluronic Acid, D-alpha-tocopheryl acetate , Terminalia Ferdinandiana , Butyloctyl Salicylate, Sebacic Acid Copolymer , Dicaprylyl Ether , Diheptyl Succinate , Diisooctyl Succinate , Ethyl Ferulat , Isononyl sononanoate , Pelargonium Graveolens Flower Oil
Package Label.Principal Display Panel
83447-003-01 (83447 003 01)
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