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| Product NDC Code | 73557-575 | ||||
|---|---|---|---|---|---|
| Drug Name | Sunscreen-lotion |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Titanium Dioxide 3.7% ...... Purpose: Sunscreen Zinc Oxide 14% ...... Purpose: Sunscreen
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DIRECTIONS Shake well before use Apply liberally 15 minutes before sun exposure and as needed. Reapply: · After 40 minutes of swimming or sweating · Immediately after towel drying · At least every 2 hours 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 your time in the sun, especially from 10 a.m. - 2 p.m. · Wear long-sleeved shirts, pants, hats, and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Argania Spinosa Kernel Oil, Auminum Hydroxide, Water (Aqua), Bisbolol, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cucumis Sativus (Cucumber) Fruit Extract, Caesalpinia Spinosa Gum, Dicaprylyl Ether, C13-15 Alkane, Carthamus Tinctorius (Safflower) Oleosomes, Caprylyl Glycol, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Helianthus Annuus (Sunflower) Seed Oil, Hydroxyacetophenone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Propanediol, Phenylpropanol, Pongamia Pinnata Seed Extract, Persea Gratissima (Avocado) Oil, Polyglyceryl-10 Mono/Dioleate, Polyhydroxystearic Acid, Rosa Rubiginosa Seed Oil, Stearyl Citrate, Sorbitan Sesquioleate, Silica, Stearic Acid, Sodium Phytate, Trioctyldodecyl Citrate, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, 2-Hexanediol
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USES 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.
Purpose
Information about the drug product’s indications for use.PURPOSE Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Sunscreen-Lotion Zinc Oxide, Titanium Dioxide DICAPRYLYL ETHER CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES C13-15 ALKANE HYDROXYACETOPHENONE PHYTATE SODIUM ALUMINUM HYDROXIDE MONOSTEARYL CITRATE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) SORBITAN SESQUIOLEATE TRIOCTYLDODECYL CITRATE PHENYLPROPANOL SHEA BUTTER MEDIUM-CHAIN TRIGLYCERIDES STEARIC ACID LEVOMENOL ALPHA-TOCOPHEROL ACETATE SUNFLOWER OIL POLYHYDROXYSTEARIC ACID (2300 MW) 1,2-HEXANEDIOL POLYGLYCERYL-10 DIOLEATE PONGAMIA PINNATA SEED WATER AVOCADO OIL CUCUMBER CAESALPINIA SPINOSA RESIN ROSA RUBIGINOSA SEED OIL GRAPE SEED OIL COCONUT OIL PROPANEDIOL SILICON DIOXIDE CAPRYLYL GLYCOL ARGAN OIL TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Box Label Container Label
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.... Ask a doctor if rash occurs.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.E-mail: [email protected] Tel: 86-21-31166566 Fax: 86-21-31166568 www.csigroup.com.cn
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use ... if rash occurs.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep out of eyes. Rinse with water to remove.
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION Protect the product in the container from excessive heat and direct sun.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS (See following 5 SECTIONs)
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API