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| Product NDC Code | 84148-002 | ||||||
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| Drug Name | Sunscreen spf 50 |
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| Type | Generic | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| Application Number | M020 | ||||||
| Labeler Name | Guangzhou Ariel Biotech 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 : ACTIVE INGREDIENTSPURPOSEOCTOCRYLENE8%…………Sunscreen ETHYLHEXYL SALICYLATE 5%.…………Sunscreen ZINC OXIDE 3%.....Sunscreen
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Use: Helps prevent sunburn
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 1.Squeeze an appropriate amount of sunscreen into the palm of yourhand and spread it evenly on the face. Don't forget that sunscreen isalso required on the neck and ears.2. Wait 5-10 minutes for the sunscreen to absorb fully.3. For outdoor activities, sunscreen must be reapplied every 2-3hours or after swimming or sweating.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS 1,2-HEXANEDIOL, AMINOMETHYL PROPANOL, AQUA, ARACHIDYL ALCOHOLARACHIDYL GLUCOSIDE, BEHENYL ALCOHOL, BETAINE, BUTYLMETHOXYDIBENZOYLMETHANE, BUTYLENE GLYCOL, CENTELLA ASIATICAEXTRACT, CETEARYL ALCOHOL, CETYL PHOSPHATE, CYCLOHEXASILOXANECYCLOPENTASILOXANE, DISODIUM EDTA, ECTOIN, GLUCOSE, GLYCERIN,GLYCERYL POLYACRYLATE, HYDROXYACETOPHENONE, HYDROXYETHYLACRYLATE / SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, JASMINUMSAMBAC (JASMINE) FLOWER EXTRACT, NEOPENTYL GLYCOL DIHEPTANOATENIACINAMIDE, PHENYLBENZIMIDAZOLE SULFONIC ACID, POLYACRYLATE-13.POLYISOBUTENE, POLYSILICONE-11, POLYSORBATE 20, POLYSORBATE 60.PROPANEDIOL, SAURURUS CHINENSIS LEAF/ROOT EXTRACT, SORBITANISOSTEARATE, STEPHANIA TETRANDRA EXTRACT, TARAXACUM OFFICINALE(DANDELION) LEAF EXTRACT, XANTHAN GUM.
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.WHEN USING SECTION When using this product, avoid contact with eyes. lf contact occurs. rinse thoroughly with water. Discontinue use if any irritation or adverse reaction occurs
Purpose
Information about the drug product’s indications for use.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Sunscreen SPF 50 Sunscreen SPF 50 POLYSORBATE 20 HYDROXYACETOPHENONE PROPANEDIOL CETYL PHOSPHATE CETOSTEARYL ALCOHOL ARACHIDYL ALCOHOL ECTOINE TARAXACUM OFFICINALE BETAZINE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) ENSULIZOLE POLYISOBUTYLENE (1000 MW) EDETATE DISODIUM AVOBENZONE GLYCERIN POLYSORBATE 60 ARACHIDYL GLUCOSIDE DOCOSANOL JASMINUM SAMBAC FLOWER DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SORBITAN ISOSTEARATE NIACINAMIDE CYCLOMETHICONE 7 BUTYLENE GLYCOL CENTELLA ASIATICA TRITERPENOIDS NEOPENTYL GLYCOL DIHEPTANOATE POLYACRYLATE-13 STEPHANIA TETRANDRA WHOLE XANTHAN GUM OCTOCRYLENE OCTOCRYLENE 1,2-HEXANEDIOL WATER AMINOMETHYLPROPANOL ZINC OXIDE ZINC OXIDE OCTISALATE OCTISALATE CYCLOMETHICONE 6 ANHYDROUS DEXTROSE SAURURUS CHINENSIS FLOWER
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.84148-002-01
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
Instructions for use
Information about safe handling and use of the drug product.WHEN USING SECTION When using this product, avoid contact with eyes. lf contact occursrinse thoroughly with water. Discontinue use if any irritation or adverse reaction occurs
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Manufactured by Guangzhou Ariel Biotech Co., Ltd No. 79 Ruihe Road, Huangpu District, Guangzhou,Guangdong, China
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 SECTION: When using this product, avoid contact with eyes. lf contact occurs, rinse thoroughly with water. Discontinue use if any irritation or adverse reaction occurs.
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: WARNINGSFor external use only.Store at room temperatureDiscontinue use if redness or irritation occurs
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