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Tinted facial sunscreen - Medication Information

Product NDC Code 84066-102
Drug Name

Tinted facial sunscreen

Type Brand
Active Ingredients
Titanium dioxide 5.6 mg/100ml
Zinc oxide 11 mg/100ml
Route TOPICAL
Dosage Form CREAM
Application Number M020
Labeler Name Guangzhou Tata Biotechnology Co., Ltd.
Packages
Package NDC Code Description
84066-102-01 50 ml in 1 bottle (84066-102-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Zinc Oxide 11%. Titanium Dioxide 5.6%

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 apply liberally 15 minutes before sun exposure reapply: after 80 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. Spendingtime in the sun increases your risk of skin cancer and early skin aging thisrisk, regularly use a sunscreen with a Broad Spertrum SPF of 15 or higher limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeved shirts,pants,hats and sunglasses. Children under 6 months of age : Ask a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Water, lsononyl lsononanoate, Dimethicone, Butylene GlycolGlycerin, Ethylhexyl Palmitate, Phenyl Trimethicone,Hydrogenated Polydecene, Polyglyceryl-3 Diisostearate, CetyPeg/Ppg-10/1 Dimethicone, Silica, DisteardimoniumHectorite, Polyhydroxystearic Acid, Sodium Chloride.Acrylates/Dimethicone Copolymer, Dimethicone/VinylDimethicone Crosspolymer, Sodium Pca, Peg-30Dipolyhydroxystearate, Tribehenin, Magnesium Stearate, Ci77492,Phenoxyethanol, Panthenol, Tocopheryl Acetate, Ci77491, Ethylhexylglycerin, Ci77499, Triethoxycaprylylsilane,PentaerythritylTetra-Di-T-Butyl Hydroxyhydrocinnamate,Simmondsia Chinensis (Jojoba) Seed Oil, Squalane.Saccharide lsomerate, Methylpropanediol, Centella AsiaticaExtract, Polygonum Cuspidatum Root Extract, ScutellariaBaicalensis Root Extract, Camellia Sinensis Leaf Extract,Hibiscus Mutabilis Flower Extract,Nelumbium SpeciosumFlower Extract,1.2-Hexanediol,Rosmarinus Officinalis(Rosemary) Leaf Extract, Chamomilla Recutita (MatricariaFlower Exiract, Hyaluronic Acid, Sodium Levulinate,Silanetriol, Citric Acid, P-Anisic Acid

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.
helps prevent sunburnifused as directed with other sun protection measures (seeDirections),decreases the risk of skin cancer and early skinaging caused by the sun

Purpose

Information about the drug product’s indications for use.
Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
TINTED FACIAL SUNSCREEN Zinc Oxide, Titanium Dioxide ETHYLHEXYL PALMITATE DIMETHICONE PHENYL TRIMETHICONE DISTEARDIMONIUM HECTORITE SODIUM CHLORIDE GLYCERIN HYDROGENATED POLYDECENE (1500 CST) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) SODIUM PYRROLIDONE CARBOXYLATE PANTHENOL FERRIC OXIDE RED TRIETHOXYCAPRYLYLSILANE POLYHYDROXYSTEARIC ACID (2300 MW) MAGNESIUM STEARATE ETHYLHEXYLGLYCERIN CENTELLA ASIATICA TRITERPENOIDS GLYCYRRHIZA GLABRA HIBISCUS MUTABILIS FLOWER TRIBEHENIN FERRIC OXIDE YELLOW ALPHA-TOCOPHEROL ACETATE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) JOJOBA OIL SCUTELLARIA BAICALENSIS ROOT PRUNUS MUME FLOWER ROSEMARY CHAMOMILE P-ANISIC ACID BUTYLENE GLYCOL SILICON DIOXIDE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SQUALANE SACCHARIDE ISOMERATE HYALURONIC ACID SILANETRIOL SODIUM LEVULINATE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE GREEN TEA LEAF NELUMBO NUCIFERA FLOWER 1,2-HEXANEDIOL POLYGLYCERYL-3 DIISOSTEARATE 2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) PEG-30 DIPOLYHYDROXYSTEARATE PHENOXYETHANOL FERROSOFERRIC OXIDE METHYLPROPANEDIOL POLYGONUM CUSPIDATUM ROOT PRUNUS PERSICA FLOWER ISONONYL ISONONANOATE CITRIC ACID MONOHYDRATE WATER

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.
labeling

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Protect the product in this container from excessive heat and direct sun

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
You can email us at [email protected] for more help!

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 and ask a doctor 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.

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.
For external use only

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

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