Otc - Active Ingredient
Zinc Oxide 24%
Onsart Mineral Sunscreen Spray
FDA Label NDC 87204-159
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Huixue Biotechnology Co., Ltd. for the product Onsart Mineral Sunscreen (NDC 87204-159). 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, inactive ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
ALOE BARBADENSIS LEAF JUICE, DIBUTYL ADIPATE, ISOOCTANE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, POLYHYDROXYSTEARIC ACID, DECYL GLUCOSIDE, PHENOXYETHANOL, TOCOPHEROL, BISABOLOL, SILICA, BUTYLENE GLYCOL, ETHYLHEXYLGLYCERIN, DIPOTASSIUM GLYCYRRHIZATE, STEARIC ACID, PROPYLENE GLYCOL, XANTHAN GUM, OPUNTIA DILLENII EXTRACT, OPHIOPOGON JAPONICUS ROOT EXTRACT, AVENA SATIVA BRAN EXTRACT, PAEONIA ALBIFLORA ROOT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, GREEN TEA （CAMELLIA SINENSIS）EXTRACT, WATER, HYALURONIC ACID, CAPRYLYL GLYCOL, ISOBUTANE, TOCOPHERYL ACETATE.
Otc - Purpose
unscreen
Indications & Usage
Uses Helps prevent sunburm. .l used as directed with other sun protection measures (see Directlens), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
Warnings For enternal use only, - Danger. Flammable. Contents under pres - De not use near fire, heat or while smoking. Do not puncture or incinerate. Store at temperatures below 120*F (48C). - De not wse on damaged or braken skin. - When using this product, keep ouf of eyes. If contact occurs, rinse thoroughly with waler. . Stop use and aak a doctor if rash occurs. + Koop out of reach of chiidren. If swailowed, get medical help or contact a Poison Contrel Center iright away. - Usn only as directed. Intentional misuse by deliberately concentrating and inhaling the comtents can be harmful or fatal.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Otc - When Using
Directions - Shake well before sach use. Spray liberally and spread evenly by hand 15 minules before sun exppsure. • Hald contsiner 4 tp & inches from the skin to apply.Rub in. -Do not apply in windy conditions. Use in a well-vent lated area. Reapply: Atter BD minutes of swimming. sweating .or immediately after towel drying A! leust every 2 hours. . Sun Protaction Measures: Spending time in the sun incresses your risk of skin cancer and early skin aging. To decrease this risk, reggularty use a sunscreen with a Biroed Spectrum SPF velue of 15 or higher and other sun protection measures includirg: - Limil time in the sun, especially from 10 am-2 pm. -Wsar long-slesve shiris, pands, hats, and Snglascs. Children under é months: Ask a doctor
Otc - Stop Use
Chest pain, rapid heart beat, faintness, or dizziness occurs sudden, unexplained weight gain occurs,your hands or feet swell.
Otc - Do Not Use
You ae under 18 years of age, Do not use it on babies and children your scalp is red.inflamed.infected, irritated, or painful
You use other medicines on the scalp.Ask a doctor before use if you hace heart disease..
Dosage & Administration
Twice each day,4 sprays (1ml)each time. 50 days supply
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