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Natural moisturizing face sunscreen and primer - Medication Information

Product NDC Code 69949-010
Drug Name

Natural moisturizing face sunscreen and primer

Type Brand
Active Ingredients
Zinc oxide 200 mg/g
Route TOPICAL
Dosage Form CREAM
Application Number part352
Labeler Name Synchronicity Spa, Inc. DBA Suntegrity
Packages
Package NDC Code Description
69949-010-01 50 g in 1 canister (69949-010-01)
69949-010-02 50 g in 1 box (69949-010-02)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Zinc Oxide 20%

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 use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours childern under 6 months: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including limit time in the sun, especially from 10am-2pm wear long sleeved shirts, pants, hats and sunglasses

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Aloe Barbadensis (Aloe Vera) Leaf Juice Certified Organic , Capric/Caprylic Triglyceride Natural or Naturally-derived ingredients , Water (Aqua), Glycerin , Hydrogenated Castor Oil , Sorbitan Sesquioleate , Magnesium Sulfate , Polyglyceryl-10 Laurate , Simmondsia Chinensis (Jojoba) Seed Oil , Helianthus Annuus (Sunflower) Seed Oil , Cucumis Sativus (Cucumber) Fruit Extract , Astaxanthin , Hyaluronic Acid , Chlorella Emersonii (Red Algae) Extract , Camellia Sinensis (Green Tea) Extract , Punica Granatum (Pomegranate) Seed Oil , Dimethicone, Citrus Sinensis (Sweet Orange) Essential Oil , Citrus Reticulata Blanco (Tangerine) Essential Oil , Polyaminopropyl Biguanide, Ethylhexylglycerin

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.
NATURAL MOISTURIZING FACE SUNSCREEN and PRIMER Zinc Oxide Zinc Oxide ZINC OXIDE ALOE VERA LEAF MEDIUM-CHAIN TRIGLYCERIDES WATER GLYCERIN HYDROGENATED CASTOR OIL SORBITAN SESQUIOLEATE MAGNESIUM SULFATE, UNSPECIFIED FORM POLYGLYCERYL-10 LAURATE JOJOBA OIL SUNFLOWER OIL CUCUMBER ASTAXANTHIN HYALURONIC ACID CHLORELLA EMERSONII GREEN TEA LEAF POMEGRANATE SEED OIL DIMETHICONE ORANGE OIL MANDARIN OIL POLYAMINOPROPYL BIGUANIDE ETHYLHEXYLGLYCERIN

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.
PRINCIPAL DISPLAY PANEL - 50 g Canister Label sun tegrity ® NATURAL MOISTURIZING FACE SUNSCREEN & PRIMER BROAD SPECTRUM SPF30 "Suntegrity ® was made in honor of my Mom and all of those who lost their lives to skin cancer. May you wear this sunscreen and smile in their memory." Tricia T. NET WT. 1.7 OZ (50 g) Principal Display Panel - 50 g Canister 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 Distributed By: Suntegrity ® Skincare Las Vegas, NV 89128

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 or Comments? Call toll free 1-888-786-5221 M-F, 10:00am-4:00pm PST.

Storage and handling

Information about safe storage and handling of the drug product.
Other Information protect this product 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 For external use only Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs When using this product keep out of eyes. Rinse with water to remove. 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