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Santo remedios piel eterna radiance sunscreen primer spf-42 - Medication Information

Product NDC Code 81352-321
Drug Name

Santo remedios piel eterna radiance sunscreen primer spf-42

Type Brand
Pharm Class Copper Absorption Inhibitor [EPC],
Decreased Copper Ion Absorption [PE]
Active Ingredients
Titanium dioxide 60 mg/ml
Zinc oxide 80 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name SANTO REMEDIO LLC
Packages
Package NDC Code Description
81352-321-00 50 ml in 1 tube (81352-321-00)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Titanium Dioxide 6% Zinc Oxide 8% 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 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures. Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients: Bis-Vinyl Dimethicone/ Dimethicone, Copolymer, Camellia Sinensis (Green Tea) Extract, Caprylic/ Capric Triglyceride, Cetyl, PEG/PPG-10/1 Dimethicone, Cocos Nucifera (Coconut) Oil, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Dimethiconol, Helianthus Annus (Sunflower) Oil, Iron Oxides (Black, Red, White, Yellow), Rubus Idaeus (Rasperry) Extract, Silica, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate.

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. Higher SPF gives more sunburn protection. Retains SPF after 80 minutes of swimming or sweating. If used as as directed with other sun protection measures (see directions), decreases the risk of 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.
SANTO REMEDIOS Piel Eterna Radiance Sunscreen Primer SPF-42 TITANIUM DIOXIDE, ZINC OXIDE GREEN TEA LEAF MEDIUM-CHAIN TRIGLYCERIDES COCONUT OIL CYCLOMETHICONE 5 CYCLOMETHICONE 4 DIMETHICONE HELIANTHUS ANNUUS FLOWERING TOP FERRIC OXIDE RED RASPBERRY SILICON DIOXIDE TETRAHEXYLDECYL ASCORBATE .ALPHA.-TOCOPHEROL ACETATE TRIDECYL SALICYLATE 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: 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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? (855) REMEDIO

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 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.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breastfeeding, Ask a health professional before use.

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 doctor if Rash occurs. Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away. If pregnant or breastfeeding, Ask a health professional before use.

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