Otc - Active Ingredient
Avobenzone 3.0%
Homosalate 9.0%
Octisalate 4.5%
Octocrylene 5.0%
Heimish Rx Hyaluronic Acid Hydrating Sunscreen Lotion
FDA Label NDC 85315-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oneand Co., Ltd. for the product Heimish Rx Hyaluronic Acid Hydrating Sunscreen (NDC 85315-001). 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 - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, 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
● 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
Otc - Do Not Use
Do not use ● on damaged or broken skin
Otc - When Using
When using this product ● keep out of eyes.Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if ● rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Person Control Center right away.
Other Safety Information
● Protect the product in this container from excessive heat and direct sun.
● You may report serious side effects to: ONEAND c/o 144 Research Drive, Hampton VA 23666
Dosage & Administration
● Apply liberally 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 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 10a.m.-2 p.m.
● Wear long-sleeved shirts, pants, hats, and sunglasses
Inactive Ingredient
Water (Aqua), Dipropylene Glycol, Methyl Methacrylate Crosspolymer, Glyceryl Polymethacrylate, Propylene Glycol, Acrylates Copolymer, Butyloctyl Salicylate, Ceteareth-20, Ethylhexyl Methoxycrylene, Polysorbate 60, Sorbitan Stearate, Caprylyl Glycol, Cetearyl Olivate, Panthenol, Sorbitan Olivate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ethylhexylglycerin, Tromethamine, Fragrance (Parfum), Isohexadecane, 1,2-Hexanediol, Ammonium Acryloyldimethyltaurate/Vp Copolymer, Tocopheryl Acetate, Polysorbate 80, Agave Tequilana Leaf Extract, Trisodium Ethylenediamine Disuccinate, Sorbitan Oleate, Glycerin, Xanthan Gum, Hyaluronic Acid
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