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Mineral sunscreen broad spectrum spf30 - Medication Information

Product NDC Code 53727-121
Drug Name

Mineral sunscreen broad spectrum spf30

Type Brand
Pharm Class Copper Absorption Inhibitor [EPC],
Decreased Copper Ion Absorption [PE]
Active Ingredients
Titanium dioxide 34.4 mg/g
Zinc oxide 48.8 mg/g
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name COSMECCA KOREA CO., LTD
Packages
Package NDC Code Description
53727-121-01 50 g in 1 tube (53727-121-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients TITANIUM DIOXIDE 3.44% ZINC OXIDE 4.88% 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 Apply liberally and evenly 15 minutes before sun exposure Reapply at least every 2 hours Use a water-resistant sunscreen if 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 a 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 time in the sun, especially from 10 a.m.-2 p.m.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients WATER (AQUA), DIMETHICONE, C12-15 ALKYL BENZOATE, PROPANEDIOL, CETYL PEG/PPG-10/1 DIMETHICONE, BUTYLOCTYL SALICYLATE, ARGANIA SPINOSA KERNEL OIL, TOCOPHERYL ACETATE, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, NIACINAMDE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, OLIVE OIL POLYGLYCERYL-6 ESTERS, POLYSILICONE-11, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, HYDROXYACETOPHENONE, MAGNESIUM SULFATE, PERSEA GRATISSIMA (AVOCADO) OIL, POLYGLYCERYL-6 PENAOLEATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, STEARIC ACID, ALPHA-GLUCAN OLIGOSACCHARIDE, SILICA, VITIS VINIFERA (GRAPE) SEED OIL, BISABOLOL, CAFFEINE, TRIETHOXYCAPRYLYLSILANE, ALUMINA, POLYMNIA SONCHIFOLIA ROOT JUICE, POLYHYDROXYSTEARIC ACID, MALTODEXTRIN, SODIUM HYALURONATE, PHENOXYETHANOL, LACTOBACILLUS, MAY CONTAIN: IRON OXIDES (CI 77491, CI 77492, CI 77499)

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.
Mineral Sunscreen Broad Spectrum SPF30 TITANIUM DIOXIDE, ZINC OXIDE LEVOMENOL CAFFEINE TRIETHOXYCAPRYLYLSILANE ALUMINUM OXIDE SMALLANTHUS SONCHIFOLIUS ROOT JUICE MALTODEXTRIN HYALURONATE SODIUM PHENOXYETHANOL WATER DIMETHICONE ALKYL (C12-15) BENZOATE PROPANEDIOL BUTYLOCTYL SALICYLATE ARGAN OIL .ALPHA.-TOCOPHEROL ACETATE SODIUM CHLORIDE DISTEARDIMONIUM HECTORITE NIACINAMIDE POLYGLYCERYL-4 ISOSTEARATE HEXYL LAURATE OLIVE OIL POLYGLYCERYL-6 ESTERS DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) 1,2-HEXANEDIOL CAPRYLYL GLYCOL HYDROXYACETOPHENONE MAGNESIUM SULFATE, UNSPECIFIED FORM AVOCADO OIL POLYGLYCERYL-10 PENTAOLEATE SHEA BUTTER STEARIC ACID .ALPHA.-GLUCAN OLIGOSACCHARIDE SILICON DIOXIDE GRAPE SEED OIL TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC CATION

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.
Package Labeling: Outer Package Inner Package Label

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts Other Information Protect the product in this container from excessive heat and direct sun

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.

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

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.
Warnings For external use only Do not use on damaged or broken skin when using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor If swallowed. get medical help or contact a Poison Control Center right away. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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