Zinc Oxide [Non-Nano]
ZINC OXIDE [NON-NANO]
Mineral Sunscreen Lotion
FDA Label NDC 87545-002
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 Origin Beauty Cosmetics Co., Ltd. for the product Mineral Sunscreen (NDC 87545-002). 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 zinc oxide [non-nano], otc - ask doctor, otc - do not use, otc - keep out of reach of children, otc - purpose, otc - stop use, 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 - Ask Doctor
Childrenunder 6 months: Ask a doctor.
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - Keep Out Of Reach Of Children
Warning section
Keep out of reach of children.
Otc - Purpose
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,
Indications & Usage
Helps prevent sunburn. If usedas directed with other sunprotection measures (seeDirections), decreases the riskof skin cancer and early skinaging caused by the sun,
Inactive Ingredient
AcetylPeptides, Allantoin, AmmoniumAcryloyldimethyltaurate/VpCopolymer, Bisabolol, CopperTripeptide-1, Cetearyl Alcohol,Disodium Edta, Ethylhexylglyc-erin, Glycerin, Hydrolyzed Sodium Hyaluronate (Low Mw),Hydroxyacetophenone,Hydroxyethyl Acrylate/SodiumAcryloyldimethyl TaurateCopolymer, Inulin LaurylCarbamate, IsononylIsononanoate, Niacinamide,Polysorbate 60, 1,2-Hexanediol,Sodium Methyl StearoylTaurate, Sodium Hyaluronate(High Mw), SorbitanIsostearate, Squalane (Olive-Derived), Tocopheryl Acetate, Vp/Hexadecene Copolymer, Water, Xanthan Gum
Warnings
For external use only
Do not use on damaged or broken skin.
When using the product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
Dosage & Administration
Apply liberally 15 minutes before sun exposure Reapply: After 40 minutes of swimming or sweating ■Immediately after towel drying ■At least every 2 hours
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Packageing
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